Phase 4
N=180
Misoprostol Dosing in BMI Greater Than 30
Pregnancy Related · Obesity · Labor Onset and Length Abnormalities
Bottom Line
View on ClinicalTrials.gov: NCT05262738 ↗Enrolled (actual)
180
Serious AEs
3.9%
Results posted
Jul 2024
Primary outcome: Primary: Interval Time From Labor Induction Initiation to Delivery (Vaginal or Cesarean) — 18.56; 21.59 hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 50 Micrograms Vaginal Misoprostol (Intervention) (Drug); 25 Micrograms Vaginal Misoprostol (Control) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Texas at Austin
- Primary completion
- Jul 2023
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 | — |
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.
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). 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.