A Randomized Trial of Induction Versus Expectant Management (ARRIVE)

The George Washington University Biostatistics Center

Status

Completed

Conditions

Labor and Delivery

Treatments

Procedure: Elective Induction of Labor

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01990612

UG1HD040512 (U.S. NIH Grant/Contract)

UG1HD040545 (U.S. NIH Grant/Contract)

UG1HD068268 (U.S. NIH Grant/Contract)

UG1HD087192 (U.S. NIH Grant/Contract)

UG1HD027915 (U.S. NIH Grant/Contract)

UG1HD034116 (U.S. NIH Grant/Contract)

UG1HD040560 (U.S. NIH Grant/Contract)

HD36801-ARRIVE

UG1HD040544 (U.S. NIH Grant/Contract)

UG1HD087230 (U.S. NIH Grant/Contract)

UG1HD034208 (U.S. NIH Grant/Contract)

U10HD036801 (U.S. NIH Grant/Contract)

UG1HD068258 (U.S. NIH Grant/Contract)

UG1HD053097 (U.S. NIH Grant/Contract)

UG1HD027869 (U.S. NIH Grant/Contract)

UG1HD040485 (U.S. NIH Grant/Contract)

UG1HD068282 (U.S. NIH Grant/Contract)

UG1HD040500 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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.

Enrollment

6,106 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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)
Refusal of blood products
Participation in another interventional study that influences management of labor at delivery or perinatal morbidity or mortality
Delivery planned elsewhere at a non-Network site