Investigating the effects of membrane stripping during vaginal birth
Maternal Consequences of Membrane Stripping During Vaginal Birth
NA · Kocaeli University · NCT06373250
This study is testing whether a procedure called membrane stripping during vaginal delivery can improve outcomes and satisfaction for new mothers.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Kocaeli University (other) |
| Locations | 1 site (Kocaeli) |
| Trial ID | NCT06373250 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the maternal outcomes associated with membrane stripping during vaginal delivery. It is designed as an experimental case-control study with a sample size of 140 participants, divided into two groups: one receiving membrane stripping and the other serving as a control. Data will be collected through various validated instruments, including the Bishop Score and Visual Analogue Scale, to assess maternal satisfaction and outcomes. Participants will be randomly assigned to either group after providing informed consent.
Who should consider this trial
Good fit: Ideal candidates for this study are primiparous women aged 18 and older, who are in labor for a vaginal birth at term gestational age.
Not a fit: Patients with high-risk pregnancies or those planning a cesarean section will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into improving maternal outcomes during vaginal births.
How similar studies have performed: Other studies have shown varying results regarding the effectiveness of membrane stripping, making this approach both relevant and potentially novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Speak and understand Turkish, * 18 years and older, * In labour for vaginal birth, * At term gestational age (37-41 weeks), * Primiparous pregnant women, * Not having a high-risk pregnancy, * Head presentation, * Without cephalopelvic disproportion, * Have gone through active labour in hospital, * Women who volunteer to take part in the research will be included. Exclusion Criteria: * Those who do not have sufficient mental health to fill out the survey form, * Having a history of previous C/S, * Caesarean section or interventional birth is planned, * Intrauterine fetal ex, * Pregnant women who wish to leave at any point in the study will be excluded.
Where this trial is running
Kocaeli
- Kocaeli University — Kocaeli, Turkey (RECRUITING)
Study contacts
- Principal investigator: Sena Dilek Aksoy, Ph.D. — Kocaeli University
- Study coordinator: Sena Dilek Aksoy, Ph.D.
- Email: sena.dilek@kocaeli.edu.tr
- Phone: +902623031000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Maternal Care for Other Abnormalities of Cervix, stripping, vaginal birth, pain, cervix, membrane