Maternal Consequences of Membrane Stripping

NCT06373250 | Recruiting

• 1 other identifier: sdilek7
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

stripping; vaginal birth; pain; cervix; membrane

Outcome Measures

Primary Outcomes (5)

• Visual analogue scale evaluation of vaginal examination pain

  The patient marks his or her own pain on a 10 cm ruler, which says no pain on one end and the most severe pain on the other end. The patient is told that there are two endpoints and to mark anywhere between these points that matches the severity of the pain. The distance between the onset of no pain and this point marked by the patient is measured and recorded in centimeters. It is stated that visual analog scale is more sensitive and reliable than other unidimensional scales in pain severity measurement. The visual analog scale is more sensitive than the simple descriptive scale.

  This scale will be filled in by the participants just before the vaginal examination.

• Visual analogue scale evaluation of vaginal examination pain

  The patient marks his or her own pain on a 10 cm ruler, which says no pain on one end and the most severe pain on the other end. The patient is told that there are two endpoints and to mark anywhere between these points that matches the severity of the pain. The distance between the onset of no pain and this point marked by the patient is measured and recorded in centimeters. It is stated that visual analog scale is more sensitive and reliable than other unidimensional scales in pain severity measurement. The visual analog scale is more sensitive than the simple descriptive scale.

  This scale will be filled in by the participants immediately after the vaginal examination.

• Evaluation of the cervix with Bishop score

  Bishop score is used to evaluate dilation, effacement, level, consistency and position of the cervix.

  This scale will be evaluated by the researcher during the vaginal examination at the beginning of labor.

• Evaluation of the amount of bleeding

  During the early postpartum period, the amount of bleeding will be determined by weighing the participant's pads.

  The amount of bleeding will be determined by weighing all pads used in the first 4 hours after birth.

• Birth Satisfaction Scale Short Form

  The Birth Satisfaction Scale-Short Form is a 10-item Likert scale. It consists of 3 sub-dimensions: quality of care, personal characteristics of the woman and stress experienced during childbirth. The lowest score on the scale is "0" and the highest score is "40", and as the score on the scale increases, so does the level of satisfaction.

  The participant will be asked to fill it in at the fourth hour after birth.

Study Arms (2)

Membrane stripping group

ACTIVE COMPARATOR

Participants in the membrane stripping group will be stripped at least once during labour. 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 is taken. Bleeding will be assessed by weighing the pads at four hours postpartum. You will also be asked to complete the short form of the Birth Satisfaction Scale.

Behavioral: Membrane stripping group

Control group

ACTIVE COMPARATOR

Participants in the control group will not undergo any membrane stripping or other cervical interventions during labour, and other routine procedures will be carried out. 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 is taken. Bleeding will be assessed by weighing the pads at four hours postpartum. You will also be asked to complete the short form of the Birth Satisfaction Scale.

Other: Control group

Interventions

Membrane stripping group BEHAVIORAL

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.

Membrane stripping group

Control group OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Speak and understand Turkish,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Köseköy, Kocaeli, 41380, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Salau JO, Onile TG, Musa AO, Gbejegbe EH, Adewole AA, Olorunfemi GO, Olumodeji AM. Effectiveness and safety of membrane sweeping in the prevention of post-term pregnancy: a randomised controlled trial. J Obstet Gynaecol. 2022 Oct;42(7):3026-3032. doi: 10.1080/01443615.2022.2126752. Epub 2022 Sep 30.

  PMID: 36178679 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sena Dilek Aksoy, Ph.D.

  Kocaeli University

  PRINCIPAL INVESTIGATOR

• Burcu Ozturk, M.Sc.

  Duzce Ataturk State Hospital

  STUDY CHAIR

• Beyza Akbaba

  Duzce Ataturk State Hospital

  STUDY CHAIR

Central Study Contacts

Sena Dilek Aksoy, Ph.D.

CONTACT

+902623031000; sena.dilek@kocaeli.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 13, 2024
• First Posted: April 18, 2024
• Study Start: April 11, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 1, 2025
• Last Updated: March 6, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)