Clinical trial NCT06373250: Maternal Consequences of Membrane Stripping
Official title: Maternal Consequences of Membrane Stripping During Vaginal Birth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maternal Care for Other Abnormalities of Cervix
Keywords: stripping
vaginal birth
pain
cervix
membrane
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Aim: This study was designed to investigate the maternal outcomes of membrane stripping during vaginal delivery.

H0: There is no difference between the maternal outcomes of pregnant women who underwent membrane stripping during vaginal delivery and those who did not.

H1: There is a difference in maternal outcomes between pregnant women who underwent membrane stripping during vaginal delivery and those who did not.

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 have been developed by the researcher from the literature on the subject.

Research application process After obtaining the necessary ethics committee and institutional permissions to conduct the research, the institution will be visited and participants who will give birth vaginally and meet the inclusion criteria for the research will be interviewed. Participants will be informed that they can participate in the study and leave the study at any time without affecting the care received in the hospital, and their voluntary consent will be obtained. Once participants are included in the study, they will be randomly assigned to membrane stripping and control groups. Membrane stripping will be applied at least once to the membrane stripping group, but will not be applied to the control group. Data will be collected through face-to-face interviews by researchers working in the hospital's delivery room. The Visual Analog Scale will be marked by the participants of the research. Visual analog scale will be filled in by case and control groups before and after routine vaginal examination. The Bishop Score will be completed during each vaginal examination. The average of the visual analog scale pain scores and Bishop scores obtained during vaginal examinations in the membrane stripping group and control group will be taken. The last bleeding control of both groups in the early postpartum period (the first 4 hours after birth) will be determined by weighing their pads and they will be asked to fill out the Birth Satisfaction Scale Short Form.

Data analysis Statistical analysis was performed using IBM SPSS Statistic 22.0 (IBM Corp., Armonk, NY, USA). Descriptive statistical methods (number, percentage, mean, standard deviation) will be used to evaluate socio-demographic data. If the data are found to be suitable for normal distribution, they will be analysed with parametric tests (Chi-square, T-test, etc.) in comparison with categorical variables, and if they are not found to be suitable for normal distribution, they will be analysed with non-parametric tests (Mann-Whitney U test, Kruskal Wallis, etc.).

Eligibility 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.

Primary outcomes:
measure: Visual analogue scale evaluation of vaginal examination pain
timeFrame: This scale will be filled in by the participants just before the vaginal examination.
measure: Visual analogue scale evaluation of vaginal examination pain
timeFrame: This scale will be filled in by the participants immediately after the vaginal examination.
measure: Evaluation of the cervix with Bishop score
timeFrame: This scale will be evaluated by the researcher during the vaginal examination at the beginning of labor.
measure: Evaluation of the amount of bleeding
timeFrame: The amount of bleeding will be determined by weighing all pads used in the first 4 hours after birth.
measure: Birth Satisfaction Scale Short Form
timeFrame: The participant will be asked to fill it in at the fourth hour after birth.
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Sena Dilek Aksoy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Duzce Ataturk State Hospital
name: Burcu Ozturk, M.Sc.
role: STUDY_CHAIR
affiliation: Duzce Ataturk State Hospital
name: Beyza Akbaba
role: STUDY_CHAIR
References:
citation: 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.