Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Breast Stimulation vs. Low Dose Oxytocin Augmentation in Women With Prior Cesarean or Grand Multiparas
NCT05510310Phase 2
Key facts
- Status
- Unknown
- Start
- Oct 2022
- Primary completion
- Oct 2024
- Countries
- 1
- Sponsor
- Galilee Medical Center
- Modality
- Peptides
- Drugs
- oxytocin
- Conditions
- dystocia
01
Overview
Phase 2, randomised, open-label trial of oxytocin in dystocia (2 arms), sponsored by Galilee Medical Center. Primary endpoint: Time interval from augmentation of labor to delivery up to 48 hours. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Breast stimulation
Breast pump for breast stimulation, alternated between nipples every 15 minutes, with a pause of 15 minutes after each 30 minutes. Maximum 12 hours.
Low-dose oxytocin
Intravenous low-dose oxytocin starting at 0.5-2 mU/min, increasing incrementally by 1-2 mU/min every 15-40 minutes. Maximum 12 hours.
03
Who it enrols
Pregnant women >= 18 years with singleton vertex gestations >= 37 weeks, history of one prior cesarean section or grandmultipara (>= 6 births), needing labor augmentation at >= 2.5 cm dilation.
04
Endpoints
Primary
Time interval from augmentation of labor to delivery
Secondary
Montevideo units in each group
Rate of women who achieved vaginal delivery
Incidence of Endometritis
Incidence of Postpartum hemorrhage
Apgar score 3 or less at 5 minutes
Beyond the preview
Go deeper on NCT05510310.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT05510310.