Genito-Pelvic PainNCT05343520
The Effect of Pelvic Floor Muscle Exercises Applied During Pregnancy on Genito-Pelvic Pain Level in Postpartum Period
A study testing Pelvic floor muscle exercises in people with Genito-Pelvic Pain and Pelvic Floor Muscle Exercise, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Abstract Introduction and hypothesis The goal of the study is figuring out the effect of pelvic floor muscle exercises on genito-pelvic pain levels during the postpartum period. Methods The data of the study, which was carried out in a randomized controlled experimental design, were collected in the antenatal… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genito-Pelvic Pain, Pelvic Floor Muscle Exercise, Pregnancy
- What is being tested?
- Pelvic floor muscle exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 30 Dec 2019
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant patients who want to join the study,
- Are primipara, not diagnosed with risky pregnancy,
- Are 30 weeks of gestation,
- Have no genito-pelvic pain pre-pregnancy,
- Have no vulvar varicosities,
- Are over the age of 18 and have no communication barrier (speaking Turkish)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Abstract Introduction and hypothesis The goal of the study is figuring out the effect of pelvic floor muscle exercises on genito-pelvic pain levels during the postpartum period.
Methods The data of the study, which was carried out in a randomized controlled experimental design, were collected in the antenatal policlinic of a public hospital between June-December 2019. There were 60 pregnant women in the experimental and control groups. Pelvic floor muscle exercises were applied to the pregnant women in the experimental group from the 30th week of gestation to the 6th postpartum week. The control group was not given pelvic floor muscle exercises training and only data collection forms were filled. During the study, the Descriptive Form, Verbal Category Scale, Pelvic Floor Distress Inventory-20, and Labour and Postpartum Information Form were applied to the pregnant women in both groups.
Read the detailed description
Introduction Some important changes are observed on the pelvic floor musculature during the pregnancy and labour. Stretching occurs in nerve, muscle, fascia and ligament structures in the pelvic floor. This affects the pelvic floor musculature, causing dysfunction and pelvic pain. As a result of the study by Paterson et al. (2009), women stated that genito-pelvic pain started during pregnancy. Women reported that genito-pelvic pain was localized only on both sides of the genital area during pregnancy, and the pain was only in the genital area in the first days of the postpartum period.
It is estimated that genito-pelvic pain occurs in approximately 22% of pregnancy [3]. Acute genito-pelvic postpartum pain is a common problem regardless of vaginal delivery or caesarean section. Acute postpartum genito-pelvic pain rates can be up to 85%. This rate is observed as 92% one day after caesarean and vaginal delivery. Postpartum pain due to acute injuries from birth usually gets better in the first 2-3 months. However, for some new mothers, acute genito-pelvic pain may persist longer after delivery.
Considering that there are over 100 million births per year worldwide, the risk of women experiencing genito-pelvic pain increases accordingly. According to these estimations, at least one million women worldwide may suffer from persistent postpartum genito-pelvic pain for one year or more after giving birth. Acute genito-pelvic pain, on the other hand, negatively affects the recovery of the perineal region in the postpartum period, problems in bladder and bowel functions, and activities of daily living. Pelvic floor muscle exercises strengthen the pelvic floor muscles and increase urethral sphincter pressure. Strengthened pelvic floor muscles provide cushioning support to the pelvic organs and prevent pelvic organ prolapse and urinary incontinence by increasing urethral sphincter pressure (and promoting urethral muscle hypertrophy). They are also involved in sexual function and continence. Pelvic floor muscle exercises are exercises that provide the strength, endurance, contraction, relaxation or development of the pelvic floor muscles. In line with this literature, this study was conducted to determine the effect of pelvic floor muscle exercises applied during pregnancy on the level of genito-pelvic pain after delivery.
- Conditions
- Genito-Pelvic Pain, Pelvic Floor Muscle Exercise, Pregnancy
- Being tested
- Pelvic floor muscle exercises
- Keywords
- Pain, Exercise, Pregnancy, Genito-Pelvic, Postpartum
- Medical subject headings
- Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle exercisesBehavioural
Pelvic floor muscle exercises were applied to the pregnant women in the experimental group from the 30th gestational week to the 6th postpartum week.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 30 pregnant women in the experimental group, pelvic floor muscle exercise was explained in detail and an exercise brochure was given in addition. Pelvic floor muscle exercises were taught by the researcher G.Y. In order for the exercise to be continued or applied correctly, the experimental group was interviewed by phone every 2 weeks. Information was given about continuing pelvic floor muscle exercises beginning from the 30th week of pregnancy until the postpartum 6th week. Receives: Behavioral: Pelvic floor muscle exercises |
| Control Group | No intervention | The control group were filled only data collection forms |
What is being measured
The primary outcome is the main question the study is designed to answer.
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Pelvic Floor Muscle Exercises effect measured with Descriptive Form
Measured: Only 30th week of gestation
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Verbal Category Scale, The scale has 5 categories. It is cascaded from "Mild" to "Unbearable". Since it is a one-dimensional and verbal scale, it is very easy to apply. This scale is based on the patient choosing the most appropriate category to determine the level of pain. It is mostly preferred in acute pain or to measure the effect of the applied treatment. Although the application of the scale is simple, it also has disadvantages. The individual has to abide by the limited options in the questionnaire
Measured: 30th week of gestation
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Verbal Category Scale, The scale has 5 categories. It is cascaded from "Mild" to "Unbearable". Since it is a one-dimensional and verbal scale, it is very easy to apply. This scale is based on the patient choosing the most appropriate category to determine the level of pain. It is mostly preferred in acute pain or to measure the effect of the applied treatment. Although the application of the scale is simple, it also has disadvantages. The individual has to abide by the limited options in the questionnaire
Measured: 6th postpartum week
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Pelvic Floor Distress Inventory-20, The aim of the inventory created by Matthew D Barber et al. (2004) is to reveal the symptoms and level of all pelvic floor disorders seen in women. Its adaptation to Turkish and its validity-reliability were performed by physiotherapist Şeyda Toprak in 2010. The inventory consists of 3 sub-dimensions and contains 20 questions in total. The answer options for each question are divided into two as No and Yes. The Yes option is rated from "Insignificant" to "Very" in itself. No=0, and the level of the answer of Yes is Insignificant=1, Little=2, Moderate=3, Much=4 points. The number of points of the 3 sub-dimensions is summed up and a number between 0-300 points is obtained. The higher the score, the more serious the individual's problems are.
Measured: 30th week of gestation
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Pelvic Floor Distress Inventory-20, The aim of the inventory created by Matthew D Barber et al. (2004) is to reveal the symptoms and level of all pelvic floor disorders seen in women. Its adaptation to Turkish and its validity-reliability were performed by physiotherapist Şeyda Toprak in 2010. The inventory consists of 3 sub-dimensions and contains 20 questions in total. The answer options for each question are divided into two as No and Yes. The Yes option is rated from "Insignificant" to "Very" in itself. No=0, and the level of the answer of Yes is Insignificant=1, Little=2, Moderate=3, Much=4 points. The number of points of the 3 sub-dimensions is summed up and a number between 0-300 points is obtained. The higher the score, the more serious the individual's problems are.
Measured: 6th postpartum week
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Labour and Postpartum Information Form, A question form covering the 15 questions about the labour and postpartum problems.
Measured: Postpartum 72 nd hour
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Labour and Postpartum Information Form, A question form covering the 15 questions about the labour and postpartum problems.
Measured: 6th postpartum week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Jun 2019
- Primary completion1 Jun 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Genito-Pelvic PainStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Husniye DINC KAYA, Istanbul University - Cerrahpasa
- Investigators
- Husniye DINC KAYA, assoc.prof, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343520
- Sponsor's protocol ID
- 13022260-300-76447
- Status last verified
- Apr 2022
- First submitted
- 17 Mar 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bortolini MA, Drutz HP, Lovatsis D, Alarab M. Vaginal delivery and pelvic floor dysfunction: current evidence and implications for future research. Int Urogynecol J. 2010 Aug;21(8):1025-30. doi: 10.1007/s00192-010-1146-9. Epub 2010 May 6.
PubMed 20445961Paterson LQ, Davis SN, Khalife S, Amsel R, Binik YM. Persistent genital and pelvic pain after childbirth. J Sex Med. 2009 Jan;6(1):215-21. doi: 10.1111/j.1743-6109.2008.01063.x.
PubMed 19170851Bartellas E, Crane JM, Daley M, Bennett KA, Hutchens D. Sexuality and sexual activity in pregnancy. BJOG. 2000 Aug;107(8):964-8. doi: 10.1111/j.1471-0528.2000.tb10397.x.
PubMed 10955426Vermelis JM, Wassen MM, Fiddelers AA, Nijhuis JG, Marcus MA. Prevalence and predictors of chronic pain after labor and delivery. Curr Opin Anaesthesiol. 2010 Jun;23(3):295-9. doi: 10.1097/aco.0b013e32833853e8.
PubMed 20446346Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
PubMed 18818022Declercq E, Cunningham DK, Johnson C, Sakala C. Mothers' reports of postpartum pain associated with vaginal and cesarean deliveries: results of a national survey. Birth. 2008 Mar;35(1):16-24. doi: 10.1111/j.1523-536X.2007.00207.x.
PubMed 18307483Rosen NO, Pukall C. Comparing the Prevalence, Risk Factors, and Repercussions of Postpartum Genito-Pelvic Pain and Dyspareunia. Sex Med Rev. 2016 Apr;4(2):126-135. doi: 10.1016/j.sxmr.2015.12.003. Epub 2016 Jan 11.
PubMed 27872022Thakar R, Stanton S. Management of genital prolapse. BMJ. 2002 May 25;324(7348):1258-62. doi: 10.1136/bmj.324.7348.1258. No abstract available.
PubMed 12028982Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Int Urogynecol J. 2017 Feb;28(2):191-213. doi: 10.1007/s00192-016-3123-4. Epub 2016 Dec 5.
PubMed 27921161Yetiskin G, Dinc Kaya H. The effect of pelvic floor muscle exercises applied during pregnancy on genito-pelvic pain level in postpartum period. Int Urogynecol J. 2022 Oct;33(10):2791-2799. doi: 10.1007/s00192-022-05225-2. Epub 2022 Jun 9.
PubMed 35678835
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pelvic Floor Muscle Exercises Applied During Pregnancy on Genito-Pelvic Pain Level in Postpartum Period
- ClinicalTrials.gov ID
- NCT05343520
- Acronym / sponsor ID
- 13022260-300-76447
- Conditions
- Genito-Pelvic Pain, Pelvic Floor Muscle Exercise, Pregnancy
- Keywords
- Pain, Exercise, Pregnancy, Genito-Pelvic, Postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 25 Apr 2022 (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.
Abstract Introduction and hypothesis The goal of the study is figuring out the effect of pelvic floor muscle exercises on genito-pelvic pain levels during the postpartum period.
Methods The data of the study, which was carried out in a randomized controlled experimental design, were collected in the antenatal policlinic of a public hospital between June-December 2019. There were 60 pregnant women in the experimental and control groups. Pelvic floor muscle exercises were applied to the pregnant women in the experimental group from the 30th week of gestation to the 6th postpartum week. The control group was not given pelvic floor muscle exercises training and only data collection forms were filled. During the study, the Descriptive Form, Verbal Category Scale, Pelvic Floor Distress Inventory-20, and Labour and Postpartum Information Form were applied to the pregnant women in both groups.
Detailed description
Introduction Some important changes are observed on the pelvic floor musculature during the pregnancy and labour. Stretching occurs in nerve, muscle, fascia and ligament structures in the pelvic floor. This affects the pelvic floor musculature, causing dysfunction and pelvic pain. As a result of the study by Paterson et al. (2009), women stated that genito-pelvic pain started during pregnancy. Women reported that genito-pelvic pain was localized only on both sides of the genital area during pregnancy, and the pain was only in the genital area in the first days of the postpartum period.
It is estimated that genito-pelvic pain occurs in approximately 22% of pregnancy [3]. Acute genito-pelvic postpartum pain is a common problem regardless of vaginal delivery or caesarean section. Acute postpartum genito-pelvic pain rates can be up to 85%. This rate is observed as 92% one day after caesarean and vaginal delivery. Postpartum pain due to acute injuries from birth usually gets better in the first 2-3 months. However, for some new mothers, acute genito-pelvic pain may persist longer after delivery.
Considering that there are over 100 million births per year worldwide, the risk of women experiencing genito-pelvic pain increases accordingly. According to these estimations, at least one million women worldwide may suffer from persistent postpartum genito-pelvic pain for one year or more after giving birth. Acute genito-pelvic pain, on the other hand, negatively affects the recovery of the perineal region in the postpartum period, problems in bladder and bowel functions, and activities of daily living. Pelvic floor muscle exercises strengthen the pelvic floor muscles and increase urethral sphincter pressure. Strengthened pelvic floor muscles provide cushioning support to the pelvic organs and prevent pelvic organ prolapse and urinary incontinence by increasing urethral sphincter pressure (and promoting urethral muscle hypertrophy). They are also involved in sexual function and continence. Pelvic floor muscle exercises are exercises that provide the strength, endurance, contraction, relaxation or development of the pelvic floor muscles. In line with this literature, this study was conducted to determine the effect of pelvic floor muscle exercises applied during pregnancy on the level of genito-pelvic pain after delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Pelvic floor muscle exercises30 pregnant women in the experimental group, pelvic floor muscle exercise was explained in detail and an exercise brochure was given in addition. Pelvic floor muscle exercises were taught by the researcher G.Y. In order for the exercise to be continued or applied correctly, the experimental group was interviewed by phone every 2 weeks. Information was given about continuing pelvic floor muscle exercises beginning from the 30th week of pregnancy until the postpartum 6th week. |
| Control Group | No intervention | –The control group were filled only data collection forms |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant patients who want to join the study,
- Are primipara, not diagnosed with risky pregnancy,
- Are 30 weeks of gestation,
- Have no genito-pelvic pain pre-pregnancy,
- Have no vulvar varicosities,
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Pelvic floor muscle exercisesPelvic floor muscle exercises were applied to the pregnant women in the experimental group from the 30th gestational week to the 6th postpartum week. | Behavioural | Experimental Group |
Primary outcome
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Time frame: Only 30th week of gestation
Pelvic Floor Muscle Exercises effect measured with Descriptive Form
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Time frame: 30th week of gestation
Verbal Category Scale, The scale has 5 categories. It is cascaded from "Mild" to "Unbearable". Since it is a one-dimensional and verbal scale, it is very easy to apply. This scale is based on the patient choosing the most appropriate category to determine the level of pain. It is mostly preferred in acute pain or to measure the effect of the applied treatment. Although the application of the scale is simple, it also has disadvantages. The individual has to abide by the limited options in the questionnaire
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Time frame: 6th postpartum week
Verbal Category Scale, The scale has 5 categories. It is cascaded from "Mild" to "Unbearable". Since it is a one-dimensional and verbal scale, it is very easy to apply. This scale is based on the patient choosing the most appropriate category to determine the level of pain. It is mostly preferred in acute pain or to measure the effect of the applied treatment. Although the application of the scale is simple, it also has disadvantages. The individual has to abide by the limited options in the questionnaire
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Time frame: 30th week of gestation
Pelvic Floor Distress Inventory-20, The aim of the inventory created by Matthew D Barber et al. (2004) is to reveal the symptoms and level of all pelvic floor disorders seen in women. Its adaptation to Turkish and its validity-reliability were performed by physiotherapist Şeyda Toprak in 2010. The inventory consists of 3 sub-dimensions and contains 20 questions in total. The answer options for each question are divided into two as No and Yes. The Yes option is rated from "Insignificant" to "Very" in itself. No=0, and the level of the answer of Yes is Insignificant=1, Little=2, Moderate=3, Much=4 points. The number of points of the 3 sub-dimensions is summed up and a number between 0-300 points is obtained. The higher the score, the more serious the individual's problems are.
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Time frame: 6th postpartum week
Pelvic Floor Distress Inventory-20, The aim of the inventory created by Matthew D Barber et al. (2004) is to reveal the symptoms and level of all pelvic floor disorders seen in women. Its adaptation to Turkish and its validity-reliability were performed by physiotherapist Şeyda Toprak in 2010. The inventory consists of 3 sub-dimensions and contains 20 questions in total. The answer options for each question are divided into two as No and Yes. The Yes option is rated from "Insignificant" to "Very" in itself. No=0, and the level of the answer of Yes is Insignificant=1, Little=2, Moderate=3, Much=4 points. The number of points of the 3 sub-dimensions is summed up and a number between 0-300 points is obtained. The higher the score, the more serious the individual's problems are.
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Time frame: Postpartum 72 nd hour
Labour and Postpartum Information Form, A question form covering the 15 questions about the labour and postpartum problems.
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups.
Time frame: 6th postpartum week
Labour and Postpartum Information Form, A question form covering the 15 questions about the labour and postpartum problems.
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 25 Apr 2022.
- Background: PubMed 20445961Bortolini MA, Drutz HP, Lovatsis D, Alarab M. Vaginal delivery and pelvic floor dysfunction: current evidence and implications for future research. Int Urogynecol J. 2010 Aug;21(8):1025-30. doi: 10.1007/s00192-010-1146-9. Epub 2010 May 6.
- Background: PubMed 19170851Paterson LQ, Davis SN, Khalife S, Amsel R, Binik YM. Persistent genital and pelvic pain after childbirth. J Sex Med. 2009 Jan;6(1):215-21. doi: 10.1111/j.1743-6109.2008.01063.x.
- Background: PubMed 10955426Bartellas E, Crane JM, Daley M, Bennett KA, Hutchens D. Sexuality and sexual activity in pregnancy. BJOG. 2000 Aug;107(8):964-8. doi: 10.1111/j.1471-0528.2000.tb10397.x.
- Background: PubMed 20446346Vermelis JM, Wassen MM, Fiddelers AA, Nijhuis JG, Marcus MA. Prevalence and predictors of chronic pain after labor and delivery. Curr Opin Anaesthesiol. 2010 Jun;23(3):295-9. doi: 10.1097/aco.0b013e32833853e8.
- Background: PubMed 18818022Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
- Background: PubMed 18307483Declercq E, Cunningham DK, Johnson C, Sakala C. Mothers' reports of postpartum pain associated with vaginal and cesarean deliveries: results of a national survey. Birth. 2008 Mar;35(1):16-24. doi: 10.1111/j.1523-536X.2007.00207.x.
- Background: PubMed 27872022Rosen NO, Pukall C. Comparing the Prevalence, Risk Factors, and Repercussions of Postpartum Genito-Pelvic Pain and Dyspareunia. Sex Med Rev. 2016 Apr;4(2):126-135. doi: 10.1016/j.sxmr.2015.12.003. Epub 2016 Jan 11.
- Background: PubMed 12028982Thakar R, Stanton S. Management of genital prolapse. BMJ. 2002 May 25;324(7348):1258-62. doi: 10.1136/bmj.324.7348.1258. No abstract available.
- Background: PubMed 27921161Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Int Urogynecol J. 2017 Feb;28(2):191-213. doi: 10.1007/s00192-016-3123-4. Epub 2016 Dec 5.
- Derived from this study: PubMed 35678835Yetiskin G, Dinc Kaya H. The effect of pelvic floor muscle exercises applied during pregnancy on genito-pelvic pain level in postpartum period. Int Urogynecol J. 2022 Oct;33(10):2791-2799. doi: 10.1007/s00192-022-05225-2. Epub 2022 Jun 9.
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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.
Husniye DINC KAYA, assoc.prof study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle exercises in people with Genito-Pelvic Pain and Pelvic Floor Muscle Exercise, run by Istanbul University - Cerrahpasa 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 6 inclusion and 1 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 25 Apr 2022. 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?
When the sample size was calculated using the G*Power Program with 95% power, 0.05 margin of error and 0.87 effect level, it was determined that at least 30 pregnant women should be recruited for each of the experimental and control groups. (time frame: Only 30th week of gestation). The study lists 7 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 NCT05343520, which also lists 10 linked publications.
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 25 Apr 2022.