Maternal Consequences of Membrane Stripping

Summary

This study aims to investigate the maternal effects of membrane stripping during vaginal birth. This study was designed as an experimental case-control study. The sample size in the study was determined by Njoku et al in 2023 to assess the effectiveness of membrane stripping applied to participants who had vaginal birth in reducing the incidence of prolonged pregnancy. Calculated based on the study conducted by. The sample size of the study was calculated using G\*Power 3.1.9.2, and the mean and standard deviation of the Bishop score in the relevant article were used to calculate the effect size. Using the mean and standard deviation of the relevant article, the blended effect size was calculated as 0.596. The minimum number of individuals that should be included in the sample of this research was calculated using G\*Power 3.1.9.2, effect size: 0.596, α= 0.05, power: 0.95 (stripping = 70, control = 70) and at least in each group in the sample size. The sample size was set at 70 participants. The research data will be collected by the researcher using the Informed Volunteer Consent Form, Participant Information Form, Bishop Scoring, Visual Analogue Scale, and Birth Satisfaction Scale Short Form, which were created by the researcher within the framework of the literature on the subject.

Conditions

• Maternal Care for Other Abnormalities of Cervix

Interventions

BEHAVIORAL

Membrane stripping group

An information form will be filled in for admission to the Primipar participating maternity unit. Membrane stripping will be performed during a vaginal examination at least once during the birth process. A visual analog scale will be completed before and after each vaginal examination. During the vaginal examination, the Bishop scoring form will be filled out. The average of the visual analogue scale and Bishop scores obtained during the vaginal examinations will be taken. At four hours postpartum, the pads are weighed and the amount of bleeding is recorded on the form. You will also be asked to complete the short form of the Birth Satisfaction Scale.

OTHER

Control group

You will be asked to fill in an information form to be admitted to the Primipar participating maternity unit. No membrane stripping are applied and no cervical interventions are made during the birth process. A visual analog scale will be completed before and after each vaginal examination. During the vaginal examination, the Bishop scoring form will be filled out. The average of the VAS and Bishop scores obtained during the vaginal examinations will be taken. At four hours postpartum, the pads are weighed and the amount of bleeding is recorded on the form. You will also be asked to complete the short form of the Birth Satisfaction Scale.

Sponsors & Collaborators

• Kocaeli University

  lead OTHER

Principal Investigators

• Sena Dilek Aksoy, Ph.D. · Kocaeli University

• Burcu Ozturk, M.Sc. · Duzce Ataturk State Hospital

• Beyza Akbaba · Duzce Ataturk State Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-04-11

Primary Completion

2025-05-31

Completion

2025-06-01

Countries

• Turkey (Türkiye)

Study Locations