Maternal Care for Other Abnormalities of CervixNCT06373250
Maternal Consequences of Membrane Stripping
A study testing Membrane stripping group in people with Maternal Care for Other Abnormalities of Cervix, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Care for Other Abnormalities of Cervix
- What is being tested?
- Membrane stripping group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Show all 10Show fewer
- Head presentation,
- Without cephalopelvic disproportion,
- Have gone through active labour in hospital,
- Women who volunteer to take part in the research will be included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal Consequences of Membrane Stripping During Vaginal Birth
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.
Read the 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.).
- Being tested
- Membrane stripping group, Control group
- Keywords
- stripping, vaginal birth, pain, cervix, membrane
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Membrane stripping groupBehavioural
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.
Control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The participant will be asked to fill it in at the fourth hour after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start31 Dec 2024
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal Care for Other Abnormalities of CervixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Dilek Aksoy, Kocaeli University
- Investigators
- Sena Dilek Aksoy, Ph.D., Principal investigator, Kocaeli UniversityBurcu Ozturk, M.Sc., Study chair, Duzce Ataturk State HospitalBeyza Akbaba, Study chair, Duzce Ataturk State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373250
- Sponsor's protocol ID
- sdilek7
- Status last verified
- Jul 2026
- First submitted
- 13 Apr 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36178679
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Consequences of Membrane Stripping During Vaginal Birth
- ClinicalTrials.gov ID
- NCT06373250
- Acronym / sponsor ID
- sdilek7
- Keywords
- stripping, vaginal birth, pain, cervix, membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Membrane stripping group | Active comparator | Behavioral: Membrane stripping groupParticipants 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. |
| Control group | Active comparator | Other: Control groupParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Speak and understand Turkish,
- 18 years and older,
- In labour for vaginal birth,
- At term gestational age (37-41 weeks),
- Primiparous pregnant women,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Membrane stripping groupAn 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. | Behavioural | Membrane stripping group |
| Control groupYou 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. | Other | Control group |
Primary outcome
Visual analogue scale evaluation of vaginal examination pain
Time frame: This scale will be filled in by the participants just before the vaginal examination.
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.
Visual analogue scale evaluation of vaginal examination pain
Time frame: This scale will be filled in by the participants immediately after the vaginal examination.
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.
Evaluation of the cervix with Bishop score
Time frame: This scale will be evaluated by the researcher during the vaginal examination at the beginning of labor.
Bishop score is used to evaluate dilation, effacement, level, consistency and position of the cervix.
Evaluation of the amount of bleeding
Time frame: The amount of bleeding will be determined by weighing all pads used in the first 4 hours after birth.
During the early postpartum period, the amount of bleeding will be determined by weighing the participant's pads.
Birth Satisfaction Scale Short Form
Time frame: The participant will be asked to fill it in at the fourth hour after birth.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 36178679Salau 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sena Dilek Aksoy, Ph.D. principal investigator
Kocaeli University
Burcu Ozturk, M.Sc. study chair
Duzce Ataturk State Hospital
Beyza Akbaba study chair
Duzce Ataturk State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Membrane stripping group in people with Maternal Care for Other Abnormalities of Cervix, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale evaluation of vaginal examination pain (time frame: This scale will be filled in by the participants just before the vaginal examination.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06373250, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.