Timeline

Clearance Jada System (intrauterine vacuum device)

Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K253642 · Where: United States

Source: FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record)

Edition published Consolidated guidelines for the prevention, diagnosis and treatment of postpartum haemorrhage (WHO, FIGO and ICM, 2025)

Issued jointly by: World Health Organization, International Federation of Gynecology and Obstetrics (FIGO), International Confederation of Midwives (ICM) · Edition: First edition, 2025.

Source: Consolidated guidelines for the prevention, diagnosis and treatment of postpartum haemorrhage

Recommended Carbetocin (heat-stable formulation)

Issued by: World Health Organization · Where: Global · Strength: Context-specific recommendation

Source: Consolidated guidelines for the prevention, diagnosis and treatment of postpartum haemorrhage

Recommended against Tranexamic acid to prevent bleeding after birth

Issued by: World Health Organization · Where: Global · Strength: Not recommended

Source: Consolidated guidelines for the prevention, diagnosis and treatment of postpartum haemorrhage

Recommended against Tranexamic acid to prevent bleeding after birth

Issued by: World Health Organization · Where: Global · Strength: Not recommended

Source: Consolidated guidelines for the prevention, diagnosis and treatment of postpartum haemorrhage

Recommended Objective measurement of postpartum blood loss

Issued by: World Health Organization · Where: Global · Strength: Recommended

Sources: Consolidated guidelines for the prevention, diagnosis and treatment of postpartum haemorrhage; WHO recommendations on the assessment of postpartum blood loss and use of a treatment bundle for postpartum haemorrhage

Recommended Objective measurement of postpartum blood loss

Issued by: World Health Organization · Where: Global · Strength: Recommended

Source: Consolidated guidelines for the prevention, diagnosis and treatment of postpartum haemorrhage

Recommended Tranexamic acid for treating postpartum haemorrhage

Issued by: World Health Organization · Where: Global · Strength: Recommended

Sources: Consolidated guidelines for the prevention, diagnosis and treatment of postpartum haemorrhage; WHO recommendation on tranexamic acid for the treatment of postpartum haemorrhage

Recommended PPH detection and first-response treatment bundle

Issued by: World Health Organization · Where: Global · Strength: Recommended

Sources: Consolidated guidelines for the prevention, diagnosis and treatment of postpartum haemorrhage; WHO recommendations on the assessment of postpartum blood loss and use of a treatment bundle for postpartum haemorrhage

Recommended Medicine to prevent heavy bleeding right after birth (oxytocin or another uterotonic)

Issued by: World Health Organization · Where: Global · Strength: Recommended

Source: Consolidated guidelines for the prevention, diagnosis and treatment of postpartum haemorrhage

Edition published USPSTF 2025: behavioral counseling interventions to support breastfeeding

Issued by: U.S. Preventive Services Task Force · Edition: USPSTF final recommendation statement, as shown on its page; also published as: Recommendation statement, JAMA 2025

Source: Breastfeeding: Primary Care Behavioral Counseling Interventions (USPSTF final recommendation statement page)

Recommended Breastfeeding support and counselling

Issued by: U.S. Preventive Services Task Force · Where: United States · Strength: B recommendation

Sources: Primary Care Behavioral Counseling Interventions to Support Breastfeeding: US Preventive Services Task Force Recommendation Statement; Primary Care Interventions to Support Breastfeeding: US Preventive Services Task Force Recommendation Statement; Breastfeeding: Primary Care Behavioral Counseling Interventions (USPSTF final recommendation statement page)

Results first posted MATISSE trial (maternal RSV vaccine, infant outcomes)

Source: A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

Clearance Elecsys sFlt-1 and Elecsys PlGF (Roche)

Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K241453 · Where: United States

Sources: FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics); 21 CFR 862.1602, Prognostic test for development or progression of preeclampsia (eCFR)

Edition published USPSTF 2024: screening and supplementation for iron deficiency in pregnancy

Issued by: U.S. Preventive Services Task Force · Edition: USPSTF final recommendation statement, as shown on its page; also published as: Recommendation statement, JAMA 2024;332(11)

Source: Iron Deficiency and Iron Deficiency Anemia During Pregnancy: Screening and Supplementation (USPSTF final recommendation statement page)

Evidence is insufficient to recommend for or against Iron supplementation and iron screening in pregnancy

Issued by: U.S. Preventive Services Task Force · Where: United States · Strength: I statement

Sources: Screening and Supplementation for Iron Deficiency and Iron Deficiency Anemia During Pregnancy: US Preventive Services Task Force Recommendation Statement; Iron Deficiency and Iron Deficiency Anemia During Pregnancy: Screening and Supplementation (USPSTF final recommendation statement page)

Evidence is insufficient to recommend for or against Iron supplementation and iron screening in pregnancy

Issued by: U.S. Preventive Services Task Force · Where: United States · Strength: I statement

Sources: Screening and Supplementation for Iron Deficiency and Iron Deficiency Anemia During Pregnancy: US Preventive Services Task Force Recommendation Statement; Iron Deficiency and Iron Deficiency Anemia During Pregnancy: Screening and Supplementation (USPSTF final recommendation statement page)

Results first posted E-MOTIVE trial (early detection and bundled treatment of postpartum haemorrhage)

Source: A Clinical Trial to Study the Effectiveness of a Care Bundle to Prevent Bleeding After a Woman Has Given Birth

Results first posted MELODY trial (nirsevimab in healthy late-preterm and term infants)

Source: A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)

Clearance Novii wireless patch system (fetal heart rate from the abdomen)

Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K231964 · Where: United States

Source: FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda)

Study completion WOMAN-2 trial (tranexamic acid in women with anaemia)

Source: World Maternal Antifibrinolytic Trial_2

Study completion MATISSE trial (maternal RSV vaccine, infant outcomes)

Source: A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

Primary completion MATISSE trial (maternal RSV vaccine, infant outcomes)

Source: A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

Primary completion WOMAN-2 trial (tranexamic acid in women with anaemia)

Source: World Maternal Antifibrinolytic Trial_2

Approval Abrysvo (RSV vaccine, Pfizer)

Authority: U.S. Food and Drug Administration · Pathway: BLA · Submission: BLA125768 · Where: United States

Sources: FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023; FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release); ABRYSVO (FDA CBER product page); Respiratory Syncytial Virus Infections (MedlinePlus health topic)

Approval Zurzuvae (zuranolone)

Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA217369 · Where: United States

Sources: FDA approves first oral treatment for postpartum depression (FDA press announcement); openFDA drugsfda record for NDA217369; ZURZUVAE drug label (openFDA record, set id f18e53b0-d0bb-422d-8de7-ab64b7292b29)

Edition published USPSTF 2023: folic acid supplementation to prevent neural tube defects (reaffirmation)

Issued by: U.S. Preventive Services Task Force · Edition: USPSTF final recommendation statement, as shown on its page; also published as: Reaffirmation recommendation statement, JAMA 2023;330(5)

Source: Folic Acid Supplementation to Prevent Neural Tube Defects: Preventive Medication (USPSTF final recommendation statement page)

Recommended Folic acid supplementation before and in early pregnancy

Issued by: U.S. Preventive Services Task Force · Where: United States · Strength: A recommendation

Sources: Folic Acid Supplementation to Prevent Neural Tube Defects: US Preventive Services Task Force Reaffirmation Recommendation Statement; Folic Acid Supplementation to Prevent Neural Tube Defects: Preventive Medication (USPSTF final recommendation statement page)

Approval Beyfortus (nirsevimab)

Authority: U.S. Food and Drug Administration · Pathway: BLA · Submission: BLA761328 · Where: United States

Sources: Drugs@FDA record for BLA761328 (BEYFORTUS), openFDA drugsfda; BEYFORTUS (nirsevimab-alip) injection label, openFDA drug label (set id 2f08fa60-f674-432d-801b-1f9514bd9b39)

Results first posted SKYLARK trial (zuranolone in severe postpartum depression)

Source: A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)

Granted SNOO Smart Sleeper (infant bassinet with supine-position system)

Authority: U.S. Food and Drug Administration · Pathway: De Novo · Submission: DEN210039 · Where: United States

Sources: FDA De Novo DEN210039: SNOO Smart Sleeper (openFDA record); De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary; 21 CFR 880.5690 Infant supine sleep system

Study completion E-MOTIVE trial (early detection and bundled treatment of postpartum haemorrhage)

Source: A Clinical Trial to Study the Effectiveness of a Care Bundle to Prevent Bleeding After a Woman Has Given Birth

Primary completion E-MOTIVE trial (early detection and bundled treatment of postpartum haemorrhage)

Source: A Clinical Trial to Study the Effectiveness of a Care Bundle to Prevent Bleeding After a Woman Has Given Birth

Study completion MELODY trial (nirsevimab in healthy late-preterm and term infants)

Source: A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)

Supplemental approval Eylea (aflibercept) for retinopathy of prematurity

Authority: U.S. Food and Drug Administration · Pathway: BLA · Submission: BLA125387 · Where: United States

Sources: FDA application BLA125387, EYLEA: openFDA Drugs@FDA record; FDA supplement approval letter, BLA 125387/S-075, Eylea (aflibercept) Injection; Eylea prescribing information for BLA125387: openFDA drug label record

Study completion CHAP (Chronic Hypertension and Pregnancy) trial

Source: Chronic Hypertension and Pregnancy (CHAP) Project

Recommended Immediate kangaroo mother care

Issued by: World Health Organization · Where: Global · Strength: Strong recommendation

Source: WHO recommendations for care of the preterm or low-birth-weight infant

Recommended Antenatal corticosteroids

Issued by: World Health Organization · Where: Global · Strength: Context-specific recommendation

Source: WHO recommendations on antenatal corticosteroids for improving preterm birth outcomes

Recommended against Antenatal corticosteroids

Issued by: World Health Organization · Where: Global · Strength: Not recommended

Sources: WHO recommendations on antenatal corticosteroids for improving preterm birth outcomes; MeSH descriptor D002821 (Chorioamnionitis)

Recommended against Antenatal corticosteroids

Issued by: World Health Organization · Where: Global · Strength: Not recommended

Source: WHO recommendations on antenatal corticosteroids for improving preterm birth outcomes

Study completion PREMOD2 trial (cord milking against delayed clamping)

Source: Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2

Primary completion PREMOD2 trial (cord milking against delayed clamping)

Source: Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2

Edition published AAP 2022 clinical practice guideline revision on hyperbilirubinemia

Source: Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation (identity record only)

Edition published NICE HealthTech guidance HTG630: PLGF-based testing to help diagnose suspected preterm pre-eclampsia

Issued by: National Institute for Health and Care Excellence (NICE) · Edition: HealthTech guidance HTG630, published in 2022 as diagnostics guidance DG49 and moved to the HTG number with its recommendations unchanged.

Source: PLGF-based testing to help diagnose suspected preterm pre-eclampsia (NICE HealthTech guidance HTG630, formerly diagnostics guidance DG49)

Recommended PlGF-based testing for suspected preterm pre-eclampsia

Issued by: National Institute for Health and Care Excellence (NICE) · Where: GB-ENG (United Kingdom) · Strength: Recommended (no graded strength label)

Source: PLGF-based testing to help diagnose suspected preterm pre-eclampsia (NICE HealthTech guidance HTG630, formerly diagnostics guidance DG49)

Edition published 2022 policy statement: Breastfeeding and the Use of Human Milk (Pediatrics)

Source: Policy Statement: Breastfeeding and the Use of Human Milk (identity record only)

Clearance INVU by Nuvo (maternal-fetal monitoring belt)

Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K221046 · Where: United States

Source: FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

Study completion SKYLARK trial (zuranolone in severe postpartum depression)

Source: A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)

Primary completion CHAP (Chronic Hypertension and Pregnancy) trial

Source: Chronic Hypertension and Pregnancy (CHAP) Project

Edition published WHO recommendations on maternal and newborn care for a positive postnatal experience (2022)

Issued by: World Health Organization · Edition: 2022

Source: WHO recommendations on maternal and newborn care for a positive postnatal experience

Primary completion SKYLARK trial (zuranolone in severe postpartum depression)

Source: A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)

Clearance Jada System (intrauterine vacuum device)

Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K212757 · Where: United States

Source: FDA 510(k) premarket notification K212757: Jada System (openFDA record)

Edition published USPSTF 2021: screening for gestational diabetes

Issued by: U.S. Preventive Services Task Force · Edition: USPSTF final recommendation statement, as shown on its page; also published as: Recommendation statement, JAMA 2021;326(6)

Source: Gestational Diabetes: Screening (USPSTF final recommendation statement page)

Recommended Glucose tests for gestational diabetes (one-step and two-step)

Issued by: U.S. Preventive Services Task Force · Where: United States · Strength: B recommendation

Sources: Screening for Gestational Diabetes: US Preventive Services Task Force Recommendation Statement; Incorrect Value in Table; Gestational Diabetes: Screening (USPSTF final recommendation statement page)

Evidence is insufficient to recommend for or against Glucose tests for gestational diabetes (one-step and two-step)

Issued by: U.S. Preventive Services Task Force · Where: United States · Strength: I statement

Sources: Screening for Gestational Diabetes: US Preventive Services Task Force Recommendation Statement; Gestational Diabetes: Screening (USPSTF final recommendation statement page)

Clearance INVU by Nuvo (maternal-fetal monitoring belt)

Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K210025 · Where: United States

Source: FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

Edition published USPSTF 2021: behavioral counseling for healthy weight and weight gain in pregnancy

Issued by: U.S. Preventive Services Task Force · Edition: Recommendation statement, JAMA 2021;325(20)

Source: Behavioral Counseling Interventions for Healthy Weight and Weight Gain in Pregnancy: US Preventive Services Task Force Recommendation Statement

Primary completion MELODY trial (nirsevimab in healthy late-preterm and term infants)

Source: A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)

Edition published USPSTF 2021: interventions for tobacco smoking cessation in adults, including pregnant persons

Issued by: U.S. Preventive Services Task Force · Edition: USPSTF final recommendation statement, as shown on its page; also published as: Recommendation statement, JAMA 2021;325(3)

Source: Tobacco Smoking Cessation in Adults, Including Pregnant Persons: Interventions (USPSTF final recommendation statement page)

Recommended Help to stop smoking in pregnancy

Issued by: U.S. Preventive Services Task Force · Where: United States · Strength: A recommendation

Sources: Interventions for Tobacco Smoking Cessation in Adults, Including Pregnant Persons: US Preventive Services Task Force Recommendation Statement; Tobacco Smoking Cessation in Adults, Including Pregnant Persons: Interventions (USPSTF final recommendation statement page)

Evidence is insufficient to recommend for or against Help to stop smoking in pregnancy

Issued by: U.S. Preventive Services Task Force · Where: United States · Strength: I statement

Sources: Interventions for Tobacco Smoking Cessation in Adults, Including Pregnant Persons: US Preventive Services Task Force Recommendation Statement; Tobacco Smoking Cessation in Adults, Including Pregnant Persons: Interventions (USPSTF final recommendation statement page)

Study completion HELIX trial (cooling in low- and middle-income countries)

Source: Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial

Study start E-MOTIVE trial (early detection and bundled treatment of postpartum haemorrhage)

Source: A Clinical Trial to Study the Effectiveness of a Care Bundle to Prevent Bleeding After a Woman Has Given Birth

Primary completion HELIX trial (cooling in low- and middle-income countries)

Source: Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial

Clearance Jada System (intrauterine vacuum device)

Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K201199 · Where: United States

Source: FDA 510(k) premarket notification K201199: Jada System (openFDA record)

Edition published WHO recommendations on drug treatment for non-severe hypertension in pregnancy (2020)

Issued by: World Health Organization · Edition: WHO recommendations, 2020.

Source: WHO recommendations on drug treatment for non-severe hypertension in pregnancy

Recommended Antihypertensive drug treatment for non-severe hypertension in pregnancy

Issued by: World Health Organization · Where: Global · Strength: Context specific recommendation

Source: WHO recommendations on drug treatment for non-severe hypertension in pregnancy

Study start MATISSE trial (maternal RSV vaccine, infant outcomes)

Source: A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

Study start SKYLARK trial (zuranolone in severe postpartum depression)

Source: A Study to Evaluate the Efficacy and Safety of SAGE-217 in Participants With Severe Postpartum Depression (PPD)

Clearance INVU by Nuvo (maternal-fetal monitoring belt)

Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K191401 · Where: United States

Sources: FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd); FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

Study start POP-HT trial (Physician Optimised Post-partum Hypertension Treatment)

Source: Physician Optimised Post-partum Hypertension Treatment Trial

Stopped early WHO ACTION-I trial

What stopped: enrollment

Source: Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries

Study start WOMAN-2 trial (tranexamic acid in women with anaemia)

Source: World Maternal Antifibrinolytic Trial_2

Study start MELODY trial (nirsevimab in healthy late-preterm and term infants)

Source: A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)

Recommended Low-dose aspirin to prevent pre-eclampsia

Issued by: National Institute for Health and Care Excellence (NICE) · Where: GB-ENG (United Kingdom) · Strength: Advise (no graded strength label on the page)

Sources: Hypertension in pregnancy: diagnosis and management (NICE guideline NG133), Recommendations chapter; Hypertension in pregnancy: diagnosis and management (NICE guideline NG133), Update information chapter; WHO recommendations on antiplatelet agents for the prevention of pre-eclampsia

Recommended Low-dose aspirin to prevent pre-eclampsia

Issued by: National Institute for Health and Care Excellence (NICE) · Where: GB-ENG (United Kingdom) · Strength: Advise (no graded strength label on the page)

Sources: Hypertension in pregnancy: diagnosis and management (NICE guideline NG133), Recommendations chapter; Hypertension in pregnancy: diagnosis and management (NICE guideline NG133), Update information chapter; WHO recommendations on antiplatelet agents for the prevention of pre-eclampsia

Recommended Antihypertensive drug treatment for non-severe hypertension in pregnancy

Issued by: National Institute for Health and Care Excellence (NICE) · Where: GB-ENG (United Kingdom) · Strength: No labelled strength (imperative wording: aim for a target)

Sources: Hypertension in pregnancy: diagnosis and management (NICE guideline NG133), Recommendations chapter; Hypertension in pregnancy: diagnosis and management (NICE guideline NG133), Context chapter; Hypertension in pregnancy: diagnosis and management (NICE guideline NG133), Update information chapter

Approval Zulresso (brexanolone injection)

Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA211371 · Where: United States

Sources: openFDA drugsfda record for NDA211371; NDA 211371 approval letter for Zulresso (brexanolone) injection; ZULRESSO (brexanolone) injection prescribing information, 2019 label; ZULRESSO (brexanolone) injection prescribing information, 2022 label (supplement 7)

Results first posted MFMU trial of treatment for mild gestational diabetes

Source: Gestational Diabetes Mellitus Trial (GDM)

Edition published NICE NG124 Specialist neonatal respiratory care for babies born preterm

Issued by: National Institute for Health and Care Excellence (NICE)

Source: Specialist neonatal respiratory care for babies born preterm (NICE guideline NG124), NLM Bookshelf record in PubMed

Edition published USPSTF 2019: interventions to prevent perinatal depression

Issued by: U.S. Preventive Services Task Force · Edition: USPSTF final recommendation statement, as shown on its page; also published as: Recommendation statement, JAMA 2019

Source: Perinatal Depression: Preventive Interventions (USPSTF final recommendation statement page)

Recommended Counselling to prevent perinatal depression

Issued by: U.S. Preventive Services Task Force · Where: United States · Strength: B recommendation

Sources: Interventions to Prevent Perinatal Depression: US Preventive Services Task Force Recommendation Statement; Perinatal Depression: Preventive Interventions (USPSTF final recommendation statement page)

Results first posted ARRIVE trial (induction at 39 weeks in low-risk first births)

Source: A Randomized Trial of Induction Versus Expectant Management

Stopped early SWEPIS trial (induction at 41 weeks)

What stopped: trial

Source: Induction of labour at 41 weeks versus expectant management and induction of labour at 42 weeks (SWEdish Post-term Induction Study, SWEPIS): multicentre, open label, randomised, superiority trial

Edition published ACOG Committee Opinion No. 736: Optimizing Postpartum Care (2018)

Issued by: American College of Obstetricians and Gynecologists (ACOG)

Source: ACOG Committee Opinion No. 736: Optimizing Postpartum Care (identity record only)

Edition published WHO recommendations: intrapartum care for a positive childbirth experience (2018)

Issued by: World Health Organization · Edition: 2018

Source: WHO recommendations: intrapartum care for a positive childbirth experience

Recommended Continuous support and a companion in labour

Issued by: World Health Organization · Where: Global · Strength: Recommended

Source: WHO recommendations: intrapartum care for a positive childbirth experience

Study completion ARRIVE trial (induction at 39 weeks in low-risk first births)

Source: A Randomized Trial of Induction Versus Expectant Management

Study start WHO ACTION-I trial

Source: The WHO ACTION-I (Antenatal CorticosTeroids for Improving Outcomes in preterm Newborns) Trial

Study start WHO Immediate KMC Study (iKMC) Registry does not say if reached

Source: Effect of immediate Kangaroo Mother Care on neonatal mortality for mothers and babies

Edition published WHO 2017: protecting, promoting and supporting breastfeeding in facilities providing maternity and newborn services

Issued by: World Health Organization · Edition: 2017

Source: Guideline: protecting, promoting and supporting breastfeeding in facilities providing maternity and newborn services

Recommended Breastfeeding support and counselling

Issued by: World Health Organization · Where: Global · Strength: Recommended

Source: Guideline: protecting, promoting and supporting breastfeeding in facilities providing maternity and newborn services

Primary completion ARRIVE trial (induction at 39 weeks in low-risk first births)

Source: A Randomized Trial of Induction Versus Expectant Management

Study completion AFFIRM trial (awareness of fetal movements)

Source: Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.

Study start PREMOD2 trial (cord milking against delayed clamping)

Source: Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2

Study completion WOMAN trial (World Maternal Antifibrinolytic Trial)

Source: World Maternal Antifibrinolytic Trial

Clearance Bakri Postpartum Balloon

Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K170622 · Where: United States

Source: FDA 510(k) premarket notification K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (openFDA record)

Primary completion AFFIRM trial (awareness of fetal movements)

Source: Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.

Edition published WHO recommendations on antenatal care for a positive pregnancy experience (2016)

Issued by: World Health Organization · Edition: WHO guideline, 2016

Source: WHO recommendations on antenatal care for a positive pregnancy experience

Study completion SUPPORT trial (CPAP against surfactant; oxygen saturation targets)

Source: Surfactant Positive Airway Pressure and Pulse Oximetry Trial

Study completion Caffeine for Apnea of Prematurity (CAP) trial

Source: Caffeine for Apnea of Prematurity (CAP)

Primary completion WOMAN trial (World Maternal Antifibrinolytic Trial)

Source: World Maternal Antifibrinolytic Trial

Study start SWEPIS trial (induction at 41 weeks) Registry does not say if reached

Source: Induction of labour at 41 weeks versus expectant management and induction of labour at 42 weeks (SWEdish Post-term Induction Study, SWEPIS): multicentre, open label, randomised, superiority trial

Edition published NICE NG25 Preterm labour and birth

Issued by: National Institute for Health and Care Excellence (NICE) · Edition: Bookshelf records dated 2015 Nov and 2022 Jun 10

Source: Preterm labour and birth (NICE guideline NG25), NLM Bookshelf records in PubMed

Study start HELIX trial (cooling in low- and middle-income countries) Registry does not say if reached

Source: Hypothermia for Encephalopathy in Low and Middle-Income Countries Trial

Study start CHAP (Chronic Hypertension and Pregnancy) trial

Source: Chronic Hypertension and Pregnancy (CHAP) Project

Clearance Draeger Jaundice Meter JM-105

Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K133175 · Where: United States

Source: FDA 510(k) premarket notification K133175: Draeger Jaundice Meter JM-105 (openFDA record and the FDA clearance letter with indications for use)

Clearance Novii wireless patch system (fetal heart rate from the abdomen)

Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K140862 · Where: United States

Source: FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd)

Study completion NEXT study (cell-free DNA for trisomy screening)

Source: Non-invasive Chromosomal Examination of Trisomy Study

Study start ARRIVE trial (induction at 39 weeks in low-risk first births) Registry does not say if reached

Source: A Randomized Trial of Induction Versus Expectant Management

Study start AFFIRM trial (awareness of fetal movements)

Source: Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.

Primary completion NEXT study (cell-free DNA for trisomy screening)

Source: Non-invasive Chromosomal Examination of Trisomy Study

Study completion MFMU trial of treatment for mild gestational diabetes

Source: Gestational Diabetes Mellitus Trial (GDM)

Clearance Cook Cervical Ripening Balloon

Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K131206 · Where: United States

Source: FDA 510(k) premarket notification K131206: COOK CERVICAL RIPENING BALLOON (openFDA record)

Study start NEXT study (cell-free DNA for trisomy screening) Registry does not say if reached

Source: Non-invasive Chromosomal Examination of Trisomy Study

Clearance Fisher and Paykel Bubble CPAP System

Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K100011 · Where: United States

Source: FDA 510(k) premarket notification K100011: FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM (openFDA record)

Edition published CDC 2010: use of WHO and CDC growth charts for children aged 0-59 months in the United States

Issued by: Centers for Disease Control and Prevention · Edition: 2010

Source: Use of World Health Organization and CDC growth charts for children aged 0-59 months in the United States

Recommended WHO Child Growth Standards

Issued by: Centers for Disease Control and Prevention · Where: United States · Strength: Recommended by CDC

Source: Use of World Health Organization and CDC growth charts for children aged 0-59 months in the United States

Study completion NICHD whole-body cooling trial for birth asphyxia

Source: Whole-Body Cooling for Birth Asphyxia in Term Infants

Study start WOMAN trial (World Maternal Antifibrinolytic Trial) Registry does not say if reached

Source: World Maternal Antifibrinolytic Trial

Primary completion SUPPORT trial (CPAP against surfactant; oxygen saturation targets)

Source: Surfactant Positive Airway Pressure and Pulse Oximetry Trial

Edition published USPSTF 2008: universal screening for hearing loss in newborns

Issued by: U.S. Preventive Services Task Force

Source: Universal screening for hearing loss in newborns: US Preventive Services Task Force recommendation statement

Primary completion MFMU trial of treatment for mild gestational diabetes

Source: Gestational Diabetes Mellitus Trial (GDM)

Study completion BEAM trial (antenatal magnesium sulfate and cerebral palsy)

Source: Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)

Primary completion Caffeine for Apnea of Prematurity (CAP) trial

Source: Caffeine for Apnea of Prematurity (CAP)

Primary completion BEAM trial (antenatal magnesium sulfate and cerebral palsy)

Source: Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)

Study start SUPPORT trial (CPAP against surfactant; oxygen saturation targets) Registry does not say if reached

Source: Surfactant Positive Airway Pressure and Pulse Oximetry Trial

Primary completion NICHD whole-body cooling trial for birth asphyxia

Source: Whole-Body Cooling for Birth Asphyxia in Term Infants

Study start MFMU trial of treatment for mild gestational diabetes Registry does not say if reached

Source: Gestational Diabetes Mellitus Trial (GDM)

Study start Early Treatment for Retinopathy of Prematurity (ETROP) trial Registry does not say if reached

Source: The Early Treatment for Retinopathy of Prematurity Study (ETROP)

Approval Curosurf (poractant alfa)

Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA020744 · Where: United States

Sources: FDA approval letter, NDA 20-744, Curosurf (poractant alfa) Intratracheal Suspension (1999); FDA application BLA020744, CUROSURF: openFDA Drugs@FDA record; Curosurf prescribing information for BLA020744: openFDA drug label record

Study start Caffeine for Apnea of Prematurity (CAP) trial Registry does not say if reached

Source: Caffeine for Apnea of Prematurity (CAP)

Study start NICHD whole-body cooling trial for birth asphyxia Registry does not say if reached

Source: Whole-Body Cooling for Birth Asphyxia in Term Infants

Approval Cafcit (caffeine citrate)

Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA020793 · Where: United States

Sources: FDA application NDA020793, CAFCIT: openFDA Drugs@FDA record; Caffeine citrate injection prescribing information for NDA020793: openFDA drug label record

Primary completion PROBIT trial (Promotion of Breastfeeding Intervention Trial)

Source: Promotion of Breastfeeding Intervention Trial

Study start BEAM trial (antenatal magnesium sulfate and cerebral palsy) Registry does not say if reached

Source: Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)

Study start PROBIT trial (Promotion of Breastfeeding Intervention Trial) Registry does not say if reached

Source: Promotion of Breastfeeding Intervention Trial

Approval Cervidil (dinoprostone vaginal insert)

Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA020411 · Where: United States

Sources: FDA new drug application NDA020411, CERVIDIL: openFDA Drugs@FDA record and Drugs@FDA approval history page; CERVIDIL drug label (openFDA record, set id f3bc9031-0620-4a50-b440-f661cadfeb1d)

Approval Pitocin (oxytocin injection)

Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA018261 · Where: United States

Sources: FDA new drug application NDA018261, PITOCIN: openFDA Drugs@FDA record and Drugs@FDA approval history page; Pitocin drug label (openFDA record, set id 6e5a66fc-e507-497c-b5ce-44a8c95898ad)