N/A
N=6,106
A Randomized Trial of Induction Versus Expectant Management
Labor and Delivery
Bottom Line
View on ClinicalTrials.gov: NCT01990612 ↗Enrolled (actual)
6,106
Serious AEs
0.1%
Results posted
Jan 2019
Primary outcome: Primary: Composite of Severe Neonatal Morbidity and Perinatal Mortality — 164; 132 Participants — p=0.049
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Elective Induction of Labor (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- The George Washington University Biostatistics Center
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of Severe Neonatal Morbidity and Perinatal Mortality |
164; 132 | 0.049 sig |
| PRIMARY Perinatal Death (Component of Primary Outcome) |
3; 2 | — |
| PRIMARY Number of Participant Infants Requiring Respiratory Support (Component of Primary Outcome) |
127; 91 | — |
| PRIMARY Number of Infants With Apgar Score ≤3 at 5 Minutes (Component of Primary Outcome) |
18; 12 | — |
| PRIMARY Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome) |
20; 14 | — |
| PRIMARY Number of Infants With Neonatal Seizure (Component of Primary Outcome) |
4; 11 | — |
| PRIMARY Number of Infants With Neonatal Infection (Component of Primary Outcome) |
12; 9 | — |
| PRIMARY Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome) |
26; 17 | — |
| PRIMARY Number of Infants With Birth Trauma (Component of Primary Outcome) |
18; 14 | — |
| PRIMARY Number of Infants With Intracranial or Subgaleal Hemorrhage (Component of Primary Outcome) |
7; 9 | — |
| PRIMARY Hypotension Requiring Vasopressor Support (Component of Primary Outcome) |
5; 2 | — |
| SECONDARY Number of Participants With Cesarean Delivery |
674; 569 | <0.001 sig |
| SECONDARY Number of Participants Who Had Uterine Incisional Extension at Cesarean Delivery |
48; 28 | 0.02 sig |
| SECONDARY Participants Who Had Operative Vaginal Delivery |
258; 222 | 0.07 |
| SECONDARY Number of Participants Who Had Chorioamnionitis |
429; 407 | 0.35 |
| SECONDARY Number of Participants With Third or Fourth Degree Perineal Laceration |
89; 103 | 0.33 |
| SECONDARY Number of Maternal Deaths |
0; 0 | — |
| SECONDARY Number of Participants Admitted to Intensive Care Unit (ICU) |
8; 4 | 0.26 |
| SECONDARY Number of Participants Experiencing Hypertensive Disorder of Pregnancy |
427; 277 | <0.001 sig |
| SECONDARY Number of Participants With Postpartum Hemorrhage |
137; 142 | 0.81 |
| SECONDARY Labor Agentry Scale Scores |
164; 168; 174; 176 | <0.001 sig |
| SECONDARY Labor Pain Scores |
9; 8; 7; 7 | <0.001 sig |
| SECONDARY Number of Participants With Maternal Postpartum Infection |
65; 50 | 0.15 |
| SECONDARY Number of Participants With Venous Thromboembolism |
1; 2 | 1.00 |
| SECONDARY Number of Participants With Indications for Cesarean Delivery |
289; 259; 332; 275; 53; 35 | — |
| SECONDARY Duration of Respiratory Support |
2911; 2968; 70; 55; 56; 36 | 0.01 sig |
| SECONDARY Number of Infants With Cephalohematoma |
90; 83 | 0.56 |
| SECONDARY Shoulder Dystocia |
65; 59 | 0.56 |
| SECONDARY Number of Infants Who Had Transfusion of Blood Products or Blood |
5; 4 | 0.75 |
| SECONDARY Number of Infants With Hyperbilirubinemia |
142; 145 | 0.91 |
| SECONDARY Number of Infants With Neonatal Hypoglycemia |
35; 37 | 0.84 |
| SECONDARY Number Infants Admitted to NICU or Intermediate Care |
394; 358 | 0.13 |
| SECONDARY Number of Hours on the Labor and Delivery Unit |
14; 20 | <0.001 sig |
| SECONDARY Maternal Postpartum Length of Hospital Stay |
317; 322; 2084; 2191; 452; 399 | 0.01 sig |
| SECONDARY Neonatal Length of Hospital Stay |
315; 321; 1904; 2030; 498; 457 | 0.002 sig |
| SECONDARY Number of Participants With Indications for Operative Vaginal Delivery |
94; 101; 156; 119; 6; 1 | — |
| SECONDARY Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery |
891; 916; 831; 863; 972; 981 | 0.88 |
Summary
A randomized clinical trial to assess whether elective induction of labor at 39 weeks of gestation compared with expectant management will improve outcomes.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01990612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.