N/A
N=2,227
Foley Bulb With Oral Misoprostol for Induction of Labor
Pregnancy · Labor, Induced
Bottom Line
View on ClinicalTrials.gov: NCT03407625 ↗Enrolled (actual)
2,227
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants With Vaginal Delivery — 869; 860 Participants — p=0.86
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Foley bulb plus Oral Misoprostol (Other); Oral Misoprostol (Other)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- Female
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Vaginal Delivery |
869; 860 | 0.86 |
| SECONDARY Time to Delivery |
17.3; 18.2 | — |
| SECONDARY Indication for Cesarean Delivery |
122; 110; 110; 115; 3; 3 | — |
| SECONDARY Dose of Oxytocin Given (mcg or mg) |
— | — |
| SECONDARY Time With Foley Bulb in Place |
5.3 | — |
| SECONDARY Presence of Chorioamnionitis |
203; 155 | — |
| SECONDARY Use of Intravenous Analgesia During Labor |
— | — |
| SECONDARY Number of Participants Used Neuraxial Analgesia During Labor |
949; 935 | — |
| SECONDARY Number of Participants Used General Anesthesia for Delivery |
29; 24 | — |
| SECONDARY Number of Participants With Meconium-stained Amniotic Fluid |
227; 234 | — |
| SECONDARY Terbutaline Use |
— | — |
| SECONDARY Number of Participants With Tachysystole |
325; 313 | — |
| SECONDARY Number of Participants With Uterine Hyperstimulation Syndrome |
184; 147 | — |
| SECONDARY Number of Participants With Excess Blood Loss |
215; 223 | — |
| SECONDARY Number of Participants With Blood Transfusion |
37; 33 | — |
| SECONDARY Number of Participants With Uterine Rupture |
0; 1 | — |
| SECONDARY Number of Participants With Unplanned Hysterectomy |
1; 0 | — |
| SECONDARY Number of Participants With Postpartum Fever |
11; 3 | — |
| SECONDARY Number of Participants With Umbilical Cord Blood pH <7.0 |
3; 4 | — |
| SECONDARY Number of Participants With an 5-minute Apgar Score Less Than 4 |
4; 4 | — |
| SECONDARY Number of Participants That Needed Mechanical Ventilation in Delivery Room (Yes/No) |
2; 4 | — |
| SECONDARY Number of Participants Administered Neonatal Antibiotics and/or Neonatal Blood Cultures |
277; 237 | — |
| SECONDARY Number of Participants With Neonatal Sepsis |
2; 1 | — |
| SECONDARY Number of Participants With NICU Admission Order |
16; 17 | — |
Summary
Induction of labor is associated with increased cesarean delivery rates, particularly in women with an unfavorable cervix. Both pharmacologic and mechanical methods are utilized for cervical ripening and labor induction. Evidence on the safety and effectiveness of various mechanical and pharmacologic methods of cervical ripening and labor induction is abundant, and yet the majority of clinical trials evaluate time to delivery, rather than mode of delivery. This is a prospective, cluster-randomized clinical trial to compare a standard method of induction at our institution (oral misoprostol) with an alternative, commonly used combination method of oral misoprostol and transcervical foley bulb in women with term pregnancies requiring induction of labor.
Eligibility Criteria
Inclusion Criteria
- 37 weeks gestation or greater
- Living, singleton fetus
- No major fetal malformations
- Cephalic presentation
- No prior uterine scar
- Intact fetal membranes
- Qualifies for prostaglandin administration according to current Parkland protocol
- Have a cervical dilation of 2 centimeters or less, measured at the level of the internal os
- Have an indication for induction or attempted induction of labor according to Parkland protocol
Exclusion Criteria
- latex allergy
- non-reassuring fetal status
- HIV
- active herpes outbreak
- Prior uterine scar
- Contraindication to prostaglandins according to current Parkland protocol
- Contraindication to vaginal delivery
Data sourced from ClinicalTrials.gov (NCT03407625). 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.