A Randomized Trial of Induction Versus Expectant Management
NCT ID: NCT01990612
Last Updated: 2019-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
6106 participants
INTERVENTIONAL
2014-03-31
2018-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Expectant Management
Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.
No interventions assigned to this group
Elective Induction of Labor
Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days
Elective Induction of Labor
Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises.
Interventions
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Elective Induction of Labor
Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score \< 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises.
Eligibility Criteria
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Inclusion Criteria
2. Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.
3. Gestational age at randomization between 38 weeks 0 days and 38 weeks 6 days inclusive based on clinical information and evaluation of the earliest ultrasound.
Exclusion Criteria
2. Plan for induction of labor prior to 40 weeks 5 days
3. Plan for cesarean delivery or contraindication to labor
4. Breech presentation
5. Signs of labor (regular painful contractions with cervical change)
6. Fetal demise or known major fetal anomaly
7. Heparin or low-molecular weight heparin during the current pregnancy
8. Placenta previa, accreta, vasa previa
9. Active vaginal bleeding greater than bloody show
10. Ruptured membranes
11. Cerclage in current pregnancy
12. Known oligohydramnios, defined as AFI \< 5 or MVP \< 2
13. Fetal growth restriction, defined as EFW \< 10th percentile
14. Known HIV positivity because of modified delivery plan
15. Major maternal medical illness associated with increased risk for adverse pregnancy outcome (for example, any diabetes mellitus, lupus, any hypertensive disorder, cardiac disease, renal insufficiency)
16. Refusal of blood products
17. Participation in another interventional study that influences management of labor at delivery or perinatal morbidity or mortality
18. Delivery planned elsewhere at a non-Network site
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
The George Washington University Biostatistics Center
OTHER
Responsible Party
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Principal Investigators
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Menachem Miodovnik, MD
Role: STUDY_DIRECTOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Rebecca Clifton, PhD
Role: PRINCIPAL_INVESTIGATOR
The George Washington University Biostatistics Center
William Grobman, MD
Role: STUDY_CHAIR
Northwestern University
Locations
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University of Alabama - Birmingham
Birmingham, Alabama, United States
Stanford University
Stanford, California, United States
University of Colorado
Denver, Colorado, United States
Northwestern University-Prentice Hospital
Chicago, Illinois, United States
Columbia University-St. Luke's Hospital
New York, New York, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
Ohio State University Hospital
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States
Dept of OB/GYN, Southwestern Medical Center, University of Texas
Dallas, Texas, United States
University of Texas - Galveston
Galveston, Texas, United States
University of Texas - Houston
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.
Mallett G, Hill K, Doherty L, Grobman WA, Reddy UM, Tita ATN, Silver RM, Rice MM, El-Sayed YY, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Costantine MM, Chien EK, Casey BM, Srinivas SK, Swamy GK, Simhan HN, Macones GA; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Maternal and Delivery Characteristics and Self-Reported Perceived Control During Labor. Obstet Gynecol. 2023 Jul 1;142(1):117-124. doi: 10.1097/AOG.0000000000005230.
Costantine MM, Sandoval GJ, Grobman WA, Reddy UM, Tita ATN, Silver RM, El-Sayed YY, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Chien EK, Casey BM, Srinivas SK, Swamy GK, Simhan HN; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network. Association of Body Mass Index With the Use of Health Care Resources in Low-Risk Nulliparous Pregnancies After 39 Weeks of Gestation. Obstet Gynecol. 2022 May 1;139(5):866-876. doi: 10.1097/AOG.0000000000004753. Epub 2022 Apr 5.
Silver RM, Rice MM, Grobman WA, Reddy UM, Tita ATN, Mallett G, Hill K, Thom EA, El-Sayed YY, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Customized Probability of Vaginal Delivery With Induction of Labor and Expectant Management in Nulliparous Women at 39 Weeks of Gestation. Obstet Gynecol. 2020 Oct;136(4):698-705. doi: 10.1097/AOG.0000000000004046.
Mallett G, Hill K, de Voest J, Bousleiman SZ, Allard D, Harris S, Salazar A, Clark K, Ortiz F, Bartholomew A, Dalton W, Craig J, Bickus M; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Characteristics Associated With Consent and Reasons for Declining in a Randomized Trial in Pregnancy. Obstet Gynecol. 2020 Oct;136(4):731-737. doi: 10.1097/AOG.0000000000003998.
El-Sayed YY, Rice MM, Grobman WA, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Elective Labor Induction at 39 Weeks of Gestation Compared With Expectant Management: Factors Associated With Adverse Outcomes in Low-Risk Nulliparous Women. Obstet Gynecol. 2020 Oct;136(4):692-697. doi: 10.1097/AOG.0000000000004055.
Dude A, Fette LM, Reddy UM, Tita ATN, Silver RM, El-Sayed YY, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Iams JD, Chien EK, Casey BM, Srinivas SK, Swamy GK, Simhan HN; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Maternal Sense of Control During Childbirth and Infant Feeding Method. Obstet Gynecol. 2020 Mar;135(3):583-590. doi: 10.1097/AOG.0000000000003697.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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HD36801-ARRIVE
Identifier Type: -
Identifier Source: org_study_id
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