A Randomized Trial of Induction Versus Expectant Management



Status:Completed
Healthy:No
Age Range:Any
Updated:2/23/2019
Start Date:March 2014
End Date:January 2018

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Induction in Nulliparous Women at 39 Weeks to Prevent Adverse Outcomes: A Randomized Controlled Trial

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

Given the reported increased risks of adverse events in pregnancies extending beyond 39 weeks
it has been hypothesized that a policy of planned elective induction at 39 weeks could
improve outcomes for the infant and the mother. For multiparous patients, especially those
with a favorable cervix, it is perhaps easy to justify an elective induction at 39 weeks
given the low risk of cesarean section. However, for nulliparous patients the current
evidence, derived mainly from retrospective observational studies, does not allow a clear
recommendation. Nevertheless, a trend towards an increased rate of elective labor induction
in pregnancies at 39 weeks has been reported, indicating that practitioners are more commonly
using elective induction at this gestational age,even as others caution against routine
elective induction prior to 41 weeks given the reported increased risk of cesarean delivery.
Ultimately, a randomized controlled trial is necessary to satisfactorily understand whether
elective induction of labor of nulliparas at 39 weeks improves neonatal and maternal
outcomes.

Inclusion Criteria:

1. Nulliparous - no previous pregnancy beyond 20 weeks

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:

1. Project gestational age at date of first ultrasound is > 20 weeks 6 days

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
We found this trial at
16
sites
10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Principal Investigator: Edward Chien, MD
Phone: 216-778-7533
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Cleveland, OH
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Alan TN Tita, MD
Phone: 205-996-6262
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: John M Thorp, Jr., MD
Phone: 919-350-6117
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Geeta K Swamy, MD
Phone: 919-668-7475
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Michael W Varner, MD
Phone: 801-585-7645
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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Chicago, Illinois 60611
Principal Investigator: William Grobman, MD
Phone: 312-503-3200
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Chicago, IL
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Columbus, Ohio 43210
Principal Investigator: Jay D Iams, MD
Phone: 614-293-5632
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Columbus, OH
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Dallas, Texas 75235
Principal Investigator: Brian M Casey, MD
Phone: 214-648-2591
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Denver, Colorado 80210
Principal Investigator: Ronald Gibbs, MD
Phone: 303-724-6685
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Galveston, Texas 77555
Principal Investigator: George R Saade, MD
Phone: 409-772-0312
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Galveston, TX
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Houston, Texas 77030
Principal Investigator: Baha Sibai, MD
Phone: 713-500-6467
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Houston, TX
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630 West 168th Street
New York, New York 10032
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New York, NY
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300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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69 Brown Street
Providence, Rhode Island 02912
(401) 863-1000
Principal Investigator: Dwight J Rouse, MD
Phone: 401-274-1122
Brown University Located in historic Providence, Rhode Island and founded in 1764, Brown University is...
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Yasser El-Sayed, MD
Phone: 650-724-6372
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Stanford, CA
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