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Labour induction of patients with waters break and unfavorable cervix: oxytocin versus misoprostol

Labour induction of patients with premature rupture of membranes and unfavorable cervix: oxytocin versus misoprostol

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-39rmvb
Enrollment
Unknown
Registered
2020-11-03
Start date
2020-03-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Rupture of Fetal Membranes

Interventions

Patients will be randomized into two groups: Group 1: 120 patients. Oxytocin at low doses of 2 mIU / min with an increase of 2 mIU / min every 20-30 minutes. Maximum dose 40 mIU / ml. Group 2: 120 pat
Drug
O42.9

Sponsors

Hospital de Clinicas de Porto Alegre
Lead Sponsor
Hospital de Clinicas de Porto Alegre
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Pregnant women admitted to the maternity of the Hospital de Clínicas de Porto Alegre (HCPA) with PROM; absence of labor; indication of labor induction; unfavorable cervix (Bishop index <4); between 34 and 41 weeks of gestation.

Exclusion criteria

Exclusion criteria: Multiple gestation; previous cesarean sections; previous transmural myomectomy; non-reassuring fetal status; more than 3 contractions in 10 minutes; placenta previa or vasa previa; umbilical cord prolapse; abnormal presentations (pelvic or transverse); active herpes infection; invasive carcinoma of the uterine cervix; having denied labor induction.

Design outcomes

Primary

MeasureTime frame
The aim of this study is demonstrate that the use of misoprostol to cervical ripening, in cases of RUPREME and unfavorable cervix, decreases the induction time until the beginning of the active phase of labor, increasing the chance of vaginal delivery.

Secondary

MeasureTime frame
Secondary outcomes will be the mean time between the start of induction and delivery, side effects of both drugs and fetal outcomes.

Countries

Brazil

Contacts

Public ContactFernanda Oliveira Castilhos

Hospital de Clinicas de Porto Alegre

fernandacastilhos@icloud.com+55-54-981117015

Outcome results

None listed

Source: REBEC (via WHO ICTRP)