NCT01990612

Brief Summary

A randomized clinical trial to assess whether elective induction of labor at 39 weeks of gestation compared with expectant management will improve outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,106

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 25, 2019

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

3.7 years

First QC Date

November 15, 2013

Results QC Date

January 2, 2019

Last Update Submit

February 19, 2019

Conditions

Labor and Delivery

Keywords

Induction of laborExpectant management of labor39 weeks gestation

Outcome Measures

Primary Outcomes (11)

  • Composite of Severe Neonatal Morbidity and Perinatal Mortality

    Includes any one of: * Perinatal death * Need for respiratory support within 72 hours after birth * Apgar score of 3 or less at 5 minutes * Hypoxic-ischemic encephalopathy * Seizure * Infection (confirmed sepsis or pneumonia) * Meconium aspiration system * Birth trauma (bone fracture, neurologic injury or retinal hemorrhage) * Intracranial or subaleal hemorrhage * Hypotension requiring vasopressor support

    delivery through 72 hours after birth

  • Perinatal Death (Component of Primary Outcome)

    Perinatal death includes antepartum stillbirth, intrapartum stillbirth and neonatal death

    antepartum pregnancy period through hospital discharge

  • Number of Participant Infants Requiring Respiratory Support (Component of Primary Outcome)

    Respiratory support includes mechanical ventilation, continuous positive airway pressure or high flow nasal cannula and cardiorespiratory resuscitation

    Delivery through discharge

  • Number of Infants With Apgar Score ≤3 at 5 Minutes (Component of Primary Outcome)

    The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.

    Delivery through 5 minutes after birth

  • Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome)

    delivery through discharge

  • Number of Infants With Neonatal Seizure (Component of Primary Outcome)

    Delivery through discharge

  • Number of Infants With Neonatal Infection (Component of Primary Outcome)

    Neonatal infection includes confirmed sepsis and/or confirmed pneumonia

    delivery through discharge

  • Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome)

    Delivery through discharge

  • Number of Infants With Birth Trauma (Component of Primary Outcome)

    Birth trauma includes clavicular, skull or other fracture; brachial plexus palsy, facial nerve palsy, retinal hemorrhage or vocal cord paralysis

    During the Delivery process

  • Number of Infants With Intracranial or Subgaleal Hemorrhage (Component of Primary Outcome)

    Intracranial or subgaleal hemorrhage includes Intraventricular hemorrhage grades III or IV, subdural hematoma, subarachnoid hematoma, and subgaleal hematoma

    delivery through disharge

  • Hypotension Requiring Vasopressor Support (Component of Primary Outcome)

    delivery through discharge

Secondary Outcomes (26)

  • Number of Participants With Cesarean Delivery

    delivery

  • Number of Participants Who Had Uterine Incisional Extension at Cesarean Delivery

    delivery

  • Participants Who Had Operative Vaginal Delivery

    delivery

  • Number of Participants Who Had Chorioamnionitis

    at any time from randomization through delivery

  • Number of Participants With Third or Fourth Degree Perineal Laceration

    delivery

  • +21 more secondary outcomes

Study Arms (2)

Expectant Management

NO INTERVENTION

Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.

Elective Induction of Labor

OTHER

Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days

Procedure: Elective Induction of Labor

Interventions

Elective Induction of LaborPROCEDURE

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.

Elective Induction of Labor

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Nulliparous - no previous pregnancy beyond 20 weeks
  • Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.
  • 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.

You may not qualify if:

  • Project gestational age at date of first ultrasound is \> 20 weeks 6 days
  • Plan for induction of labor prior to 40 weeks 5 days
  • Plan for cesarean delivery or contraindication to labor
  • Breech presentation
  • Signs of labor (regular painful contractions with cervical change)
  • Fetal demise or known major fetal anomaly
  • Heparin or low-molecular weight heparin during the current pregnancy
  • Placenta previa, accreta, vasa previa
  • Active vaginal bleeding greater than bloody show
  • Ruptured membranes
  • Cerclage in current pregnancy
  • Known oligohydramnios, defined as AFI \< 5 or MVP \< 2
  • Fetal growth restriction, defined as EFW \< 10th percentile
  • Known HIV positivity because of modified delivery plan
  • 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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

University of Alabama - Birmingham

Birmingham, Alabama, 35233, United States

Location

Stanford University

Stanford, California, 94305-5317, United States

Location

University of Colorado

Denver, Colorado, 80045, United States

Location

Northwestern University-Prentice Hospital

Chicago, Illinois, 60611, United States

Location

Columbia University-St. Luke's Hospital

New York, New York, 10032, United States

Location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44109, United States

Location

Ohio State University Hospital

Columbus, Ohio, 43210, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Brown University

Providence, Rhode Island, 02905, United States

Location

Dept of OB/GYN, Southwestern Medical Center, University of Texas

Dallas, Texas, 75235-9032, United States

Location

University of Texas - Galveston

Galveston, Texas, 77555, United States

Location

University of Texas - Houston

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (7)

  • 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.

    PMID: 30089070RESULT

  • 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; 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.

    PMID: 37290106DERIVED

  • 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.

    PMID: 35576345DERIVED

  • 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.

    PMID: 32925634DERIVED

  • 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.

    PMID: 32925629DERIVED

  • 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.

    PMID: 32925628DERIVED

  • 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.

    PMID: 32028504DERIVED

Results Point of Contact

Title
Dr. William Grobman
Organization
Northwestern University
w-grobman@northwestern.edu
312-472-4661

Study Officials

  • Menachem Miodovnik, MD

    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    STUDY DIRECTOR

  • Rebecca Clifton, PhD

    The George Washington University Biostatistics Center

    PRINCIPAL INVESTIGATOR

  • William Grobman, MD

    Northwestern University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized trial of 6000 women at 38 weeks 0 days to 38 weeks 6 days randomized to one of two arms: elective induction of labor between 39 weeks 0 days and 39 weeks 4 days; or expectant management (unless a medical indication arises) until at least 40 weeks 5 days.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2013

First Posted

November 21, 2013

Study Start

March 1, 2014

Primary Completion

November 1, 2017

Study Completion

January 1, 2018

Last Updated

February 21, 2019

Results First Posted

January 25, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

The dataset will be shared per NIH policy after the completion and publication of the main analyses. Requests for datasets can be sent to mfmudatasets@bsc.gwu.edu.

Locations

US(16)