Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373250
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-13
Brief Title:
Maternal Consequences of Membrane Stripping
Sponsor:
Kocaeli University
Organization:
Kocaeli University
Study Overview
Official Title:
Maternal Consequences of Membrane Stripping During Vaginal Birth
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 GPower 3192 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 0596 The minimum number of individuals that should be included in the sample of this research was calculated using GPower 3192 effect size 0596 α 005 power 095 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 hospitals 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 220 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
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 hospitals 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 220 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None