Phase 4
Completed N=180
Misoprostol Dosing in BMI Greater Than 30
Pregnancy Related · Obesity · Labor Onset and Length Abnormalities
Source: ClinicalTrials.gov NCT05262738 ↗
Enrolled (actual)
180
Serious AEs
3.9%
Results posted
Jul 2024
Primary outcomePrimary: Interval Time From Labor Induction Initiation to Delivery (Vaginal or Cesarean) — 18.56; 21.59 hours
◆ Published Evidence
Emerging
10citations · ~5 / year
Optimal misoprostol dosing among patients with a body mass index greater than 30: a randomized controlled trial.
Summary
The investigators are performing a randomized controlled-trial investigating if 50mcg (compared to 25 mcg) of vaginal misoprostol reduces the time from induction start to delivery in obese women.
Linked Publications
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Optimal misoprostol dosing among patients with a body mass index greater than 30: a randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Interval Time From Labor Induction Initiation to Delivery (Vaginal or Cesarean) |
18.56; 21.59 | — |
| SECONDARY Interval Time From Labor Induction to Vaginal Delivery |
17.20; 19.00 | — |
| SECONDARY Number of Cesarean Deliveries |
25; 24 | — |
| SECONDARY Number of Participants Exhibiting Uterine Tachysystole |
20; 9 | — |
| SECONDARY Number of Participants Exhibiting Uterine Tachysystole With Fetal Decelerations |
2; 2 | — |
| SECONDARY Number of Participants Receiving Terbutaline |
2; 1 | — |
| SECONDARY Number of Participants Diagnosed With Clinical Chorioamnionitis |
8; 10 | — |
| SECONDARY Number of Participants Diagnosed With Postpartum Hemorrhage |
12; 17 | — |
| SECONDARY Patient Satisfaction Six Simple Questions, Question 1 |
6; 6 | — |
| SECONDARY Patient Satisfaction Six Simple Questions, Question 2 |
7; 7 | — |
| SECONDARY Patient Satisfaction Six Simple Questions, Question 3 |
2; 2 | — |
| SECONDARY Patient Satisfaction Six Simple Questions, Question 4 |
6; 7 | — |
| SECONDARY Patient Satisfaction Six Simple Questions, Question 5 |
2; 2 | — |
| SECONDARY Patient Satisfaction Six Simple Questions, Question 6 |
7; 6.5 | — |
| SECONDARY Patient Satisfaction (Labor Pain Scale, Question 1) |
8; 8 | — |
| SECONDARY Patient Satisfaction (Labor Pain Scale, Question 2) |
6; 6.5 | — |
| SECONDARY Patient Satisfaction (Labor Pain Scale, Question 3) |
5; 5 | — |
| SECONDARY Patient Satisfaction (Labor Pain Scale, Question 4) |
2; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Singleton gestation
- Age 18 years or older
- Gestational age >= 36 weeks
- BMI >= 30 kg/m2 at time of labor induction
- Cephalic presentation (including successful external cephalic version)
- Cervical dilation 3cm
- No intention to proceed with cervical ripening (not indicated, favorable bishop score, plan for Oxytocin administration, etc.)
- Uterine tachysystole (defined as >= 5 contractions within a 10m period)
- Fetal Growth Restriction (EFW <= 5% or elevated/absent/reversed Umbilical Artery dopplers)
- Inability to give consent (inability to read/write in English or Spanish)
Data sourced from ClinicalTrials.gov (NCT05262738) and the linked publication. 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. Informational only — not medical advice.