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Once-only membrane sweeping at full-term for preventing prolonged pregnancy: a double-blind randomised controlled study at Nnewi, Nigeria

Once-only membrane sweeping at full-term for preventing prolonged pregnancy: a double-blind randomised controlled study at Nnewi, Nigeria

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202603628192794
Enrollment
168
Registered
2026-03-23
Start date
2026-03-17
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Pregnancy and Childbirth

Interventions

Sponsors

OKOYE SAMUEL CHIDIEBERE
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: This study will include women with low risk and uncomplicated pregnancies without contraindication to vaginal delivery. Primigravid women will be recruited. Also included will be, nulliparous, primiparous, multiparous and grand-multiparous gravid women. The participants will be within 19-44 years and should be at full term pregnancy (from 39 weeks to 40 weeks plus 6days gestation). The gestational age should be clear and known. Each participant should be a booked pregnant woman with a single fetus in cephalic presentation, longitudinal lie with intact membrane and not in labour. They should present within the study period of six months. A written informed consent will be obtained from all participants that will undergo this study.

Exclusion criteria

Exclusion criteria: The participants that will be excluded from the study include; 1. Those with unbooked pregnancies., unsure of date with no early ultrasound dating, preterm labour, prolonged pregnancy, post-term pregnancy, membrane rupture prior to recruitment, multiple pregnancy, fetal anomalies, or intrauterine fetal death. 2. Woman with one or more previous caesarean sections. 3. Pregnant women with contraindication to vaginal delivery. 4. Participants with medical conditions like diabetes mellitus, hypertensive disorders, sickle cell disease, renal disease etc. 5. Those with uterine fibroids. 6. Women with inaccessible cervix or close cervix. 7. Pregnant women already booked for elective vaginal or operative delivery for any reason 8. Those that withhold consent.

Design outcomes

Primary

MeasureTime frame
1.The proportion of participants whose pregnancy become prolonged pregnancy (reaches 41 weeks plus 3 days).

Secondary

MeasureTime frame
1. The proportion of participants that had vaginal delivery. 2. The proportion of participants who had elective induction of labour. 3. The time interval from point of the intervention (study or control) to onset of spontaneous labour. 4. The APGAR score of the neonate at delivery. 5 The proportion of participants that had spontaneous onset of labour

Countries

Nigeria

Contacts

Public ContactCONFIDENCE OGBOMADE

SENIOR REGISTRAR

infoforconfy96@gmail.com+2347068078562

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026