Perineum; InjuryNCT06162312
Efficacy of Antenatal Perineal Massage in Reducing Postpartum Morbidities
A study testing Antenatal perineal massage in people with Perineum; Injury and Anal Incontinence, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
A randomized controlled trial was undertaken at Rajavithi Hospital, Bangkok, Thailand, encompassing 106 primigravidae within the period of December 2023 to June 2024. The intervention group underwent antepartum perineal massage, starting at the 34th - 35th week of gestation and extending until delivery, while the… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perineum; Injury, Anal Incontinence, Urinary Incontinence
- What is being tested?
- Antenatal perineal massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteThailand
- Study dates
- 1 Dec 2023to 30 Jul 2024
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparous singleton pregnant women older than 18 years at 34 - 35 weeks of gestation
- The fetus has a cephalic presentation.
- Proficiency in the Thai language for communication
- Willingness to engage in research projects
- Intending to deliver at Rajavithi Hospital
Who cannot join
- Genital infections such as herpes or candida vulvovaginitis.
- Previous Caesarean section.
- Pregnant women who underwent epidural anesthesia or required instrumental delivery
- Pregnant women with a history of chronic cough, urinary incontinence, Anal incontinence, pelvic floor dysfunction, or connective tissue diseases
- Contraindications to vaginal childbirth, such as placenta previa or Placenta accreta spectrum disorder
- Birth before arrival
Trial locations and contacts
1 site in 1 country.
About this study
A randomized controlled trial was undertaken at Rajavithi Hospital, Bangkok, Thailand, encompassing 106 primigravidae within the period of December 2023 to June 2024. The intervention group underwent antepartum perineal massage, starting at the 34th - 35th week of gestation and extending until delivery, while the control group did not receive such intervention. The primary outcome evaluated was the incidence of anal incontinence at the 3-month postpartum. Secondary outcomes included the duration of each labor stage, perineal tears and their degrees, episiotomy occurrences, Apgar scores at 1 and 5 minutes, postpartum pain within 24 hours, dyspareunia, and urinary incontinence at the 3-month postpartum.
Read the detailed description
Vaginal births often result in perineal trauma, leading to substantial morbidity. This study hypothesized that antenatal perineal massage (APM) could mitigate the incidence of perineal injuries and related postpartum morbidities.
Participants at 34-35 weeks of gestation were randomly assigned by a computer program to either the Antenatal Perineal Massage (APM ) group or the control group. The APM group received training in self-perineal massage and performed a daily 5-minute massage using water-based jelly until delivery, while the control group did not receive such intervention.
The technique involved inserting the thumb finger 3-5 cm into the vagina, using a water-based jelly for lubrication. The procedure included maintaining the thumb steady on the perineum for 1 minute, applying up-and-down pressure for 1 minute, and performing downward and sideways sweeping motions for 3 minutes. Initial massage sessions were conducted under supervision at the antenatal clinic.
Participants were advised to discontinue APM in case of premature rupture of membranes (PROM), bleeding, or infection, seeking prompt hospital management. Additionally, they were instructed to maintain a diary documenting their daily APM sessions.
Both groups received standard antenatal, intrapartum, and postpartum care. Obstetric care providers, investigator and outcomes assessor remained blinded to participants' study group allocations.
During labor at the casualty department, routine care was administered without intervention in labor management or cesarean delivery decisions. Recorded data encompassed the duration of each labor stage, perineal tears and their degrees, episiotomy occurrences, urgency for cesarean section or operative vaginal delivery, infant weight, sex, Apgar scores at 1 and 5 minutes, and postpartum pain using a verbal numerical rating scale within 24 hours.
Participants were followed up at 3 months post-delivery to evaluate the anal incontinence, urinary incontinence (assessed via the validated Thai version of Pelvic Floor Distress Inventory - 20 (PFDI-20)), and dyspareunia (using a verbal numerical rating scale
- Conditions
- Perineum; Injury, Anal Incontinence, Urinary Incontinence
- Being tested
- Antenatal perineal massage
- Keywords
- antenatal perineal massage, postpartum morbidities, Anal Incontinence
- Medical subject headings
- Wounds and Injuries, Encopresis, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal perineal massageOther
Participants at 34-35 weeks of gestation were received training in self-perineal massage and performed a daily 5-minute massage using water-based jelly until delivery to compare with standard obstetric care on postpartum morbidities
| Study group | Role | What they receive |
|---|---|---|
| Antenatal perineal massage | Experimental | daily 5-minute perineal massage from the 34th or 35th week of pregnancy until delivery Receives: Other: Antenatal perineal massage |
| Control | No intervention | standard antenatal, intrapartum and postpartum care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anal incontinence
To compare anal incontinence between intervention group and control group. Assessed via the validated Thai version of Pelvic Floor Distress Inventory - 20 (PFDI-20)
Measured: At 3 months post-delivery
Secondary outcomes (7)
Urinary incontinence
To compare urinary incontinence between intervention group and control group. Assessed via the validated Thai version of Pelvic Floor Distress Inventory - 20 (PFDI-20)
Measured: At 3 months post-delivery
Dyspareunia
To compare dyspareunia between intervention group and control group. Assessed via the verbal numerical rating scale
Measured: At 3 months post-delivery
Postpartum pain
To compare postpartum pain between intervention group and control group. Assessed via the verbal numerical rating scale
Measured: At 24 hours post-delivery
Duration of each labor stage
To compare duration of first, second and third stage of labor stage between intervention group and control group.
Measured: During delivery
Perineal tears and their degrees
To compare perineal tear occurrences and their degrees between intervention group and control group.
Measured: During delivery
Episiotomy
To compare episiotomy occurrences between intervention group and control group.
Measured: During delivery
Apgar scores
To compare Apgar scores at 1 and 5 minutes of the newborns between intervention group and control group.
Measured: During delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Dec 2023
- Primary completion30 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Perineum; InjuryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162312
- Sponsor's protocol ID
- 182/2566
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moossdorff-Steinhauser HFA, Berghmans BCM, Spaanderman MEA, Bols EMJ. Urinary incontinence 6 weeks to 1 year post-partum: prevalence, experience of bother, beliefs, and help-seeking behavior. Int Urogynecol J. 2021 Jul;32(7):1817-1824. doi: 10.1007/s00192-020-04644-3. Epub 2021 Jan 23.
PubMed 33484286Moossdorff-Steinhauser HFA, Berghmans BCM, Spaanderman MEA, Bols EMJ. Prevalence, incidence and bothersomeness of urinary incontinence between 6 weeks and 1 year post-partum: a systematic review and meta-analysis. Int Urogynecol J. 2021 Jul;32(7):1675-1693. doi: 10.1007/s00192-021-04877-w. Epub 2021 Jun 17.
PubMed 34142179Aasheim V, Nilsen ABV, Reinar LM, Lukasse M. Perineal techniques during the second stage of labour for reducing perineal trauma. Cochrane Database Syst Rev. 2017 Jun 13;6(6):CD006672. doi: 10.1002/14651858.CD006672.pub3.
PubMed 28608597Dieb AS, Shoab AY, Nabil H, Gabr A, Abdallah AA, Shaban MM, Attia AH. Perineal massage and training reduce perineal trauma in pregnant women older than 35 years: a randomized controlled trial. Int Urogynecol J. 2020 Mar;31(3):613-619. doi: 10.1007/s00192-019-03937-6. Epub 2019 Apr 2.
PubMed 30941442Mei-dan E, Walfisch A, Raz I, Levy A, Hallak M. Perineal massage during pregnancy: a prospective controlled trial. Isr Med Assoc J. 2008 Jul;10(7):499-502.
PubMed 18751626Tin RY, Schulz J, Gunn B, Flood C, Rosychuk RJ. The prevalence of anal incontinence in post-partum women following obstetrical anal sphincter injury. Int Urogynecol J. 2010 Aug;21(8):927-32. doi: 10.1007/s00192-010-1134-0. Epub 2010 Apr 27.
PubMed 20422153Ugwu EO, Iferikigwe ES, Obi SN, Eleje GU, Ozumba BC. Effectiveness of antenatal perineal massage in reducing perineal trauma and post-partum morbidities: A randomized controlled trial. J Obstet Gynaecol Res. 2018 Jul;44(7):1252-1258. doi: 10.1111/jog.13640. Epub 2018 Apr 2.
PubMed 29607580Bunyavejchevin S, Ruanphoo P. Thai translation and validation of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) and Pelvic Floor Distress Inventory (PFDI-20). Int Urogynecol J. 2022 Nov;33(11):3137-3142. doi: 10.1007/s00192-022-05148-y. Epub 2022 Apr 7.
PubMed 35389055Abdelhakim AM, Eldesouky E, Elmagd IA, Mohammed A, Farag EA, Mohammed AE, Hamam KM, Hussein AS, Ali AS, Keshta NHA, Hamza M, Samy A, Abdel-Latif AA. Antenatal perineal massage benefits in reducing perineal trauma and postpartum morbidities: a systematic review and meta-analysis of randomized controlled trials. Int Urogynecol J. 2020 Sep;31(9):1735-1745. doi: 10.1007/s00192-020-04302-8. Epub 2020 May 12.
PubMed 32399905
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Antenatal Perineal Massage in Reducing Postpartum Morbidities
- ClinicalTrials.gov ID
- NCT06162312
- Acronym / sponsor ID
- 182/2566
- Conditions
- Perineum; Injury, Anal Incontinence, Urinary Incontinence
- Keywords
- antenatal perineal massage, postpartum morbidities, Anal Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 8 Dec 2023 (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.
A randomized controlled trial was undertaken at Rajavithi Hospital, Bangkok, Thailand, encompassing 106 primigravidae within the period of December 2023 to June 2024. The intervention group underwent antepartum perineal massage, starting at the 34th - 35th week of gestation and extending until delivery, while the control group did not receive such intervention. The primary outcome evaluated was the incidence of anal incontinence at the 3-month postpartum. Secondary outcomes included the duration of each labor stage, perineal tears and their degrees, episiotomy occurrences, Apgar scores at 1 and 5 minutes, postpartum pain within 24 hours, dyspareunia, and urinary incontinence at the 3-month postpartum.
Detailed description
Vaginal births often result in perineal trauma, leading to substantial morbidity. This study hypothesized that antenatal perineal massage (APM) could mitigate the incidence of perineal injuries and related postpartum morbidities.
Participants at 34-35 weeks of gestation were randomly assigned by a computer program to either the Antenatal Perineal Massage (APM ) group or the control group. The APM group received training in self-perineal massage and performed a daily 5-minute massage using water-based jelly until delivery, while the control group did not receive such intervention.
The technique involved inserting the thumb finger 3-5 cm into the vagina, using a water-based jelly for lubrication. The procedure included maintaining the thumb steady on the perineum for 1 minute, applying up-and-down pressure for 1 minute, and performing downward and sideways sweeping motions for 3 minutes. Initial massage sessions were conducted under supervision at the antenatal clinic.
Participants were advised to discontinue APM in case of premature rupture of membranes (PROM), bleeding, or infection, seeking prompt hospital management. Additionally, they were instructed to maintain a diary documenting their daily APM sessions.
Both groups received standard antenatal, intrapartum, and postpartum care. Obstetric care providers, investigator and outcomes assessor remained blinded to participants' study group allocations.
During labor at the casualty department, routine care was administered without intervention in labor management or cesarean delivery decisions. Recorded data encompassed the duration of each labor stage, perineal tears and their degrees, episiotomy occurrences, urgency for cesarean section or operative vaginal delivery, infant weight, sex, Apgar scores at 1 and 5 minutes, and postpartum pain using a verbal numerical rating scale within 24 hours.
Participants were followed up at 3 months post-delivery to evaluate the anal incontinence, urinary incontinence (assessed via the validated Thai version of Pelvic Floor Distress Inventory - 20 (PFDI-20)), and dyspareunia (using a verbal numerical rating scale
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antenatal perineal massage | Experimental | Other: Antenatal perineal massagedaily 5-minute perineal massage from the 34th or 35th week of pregnancy until delivery |
| Control | No intervention | –standard antenatal, intrapartum and postpartum care |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Nulliparous singleton pregnant women older than 18 years at 34 - 35 weeks of gestation
- The fetus has a cephalic presentation.
- Proficiency in the Thai language for communication
- Willingness to engage in research projects
- Intending to deliver at Rajavithi Hospital
Key exclusion criteria (6 listed)
- Genital infections such as herpes or candida vulvovaginitis.
- Previous Caesarean section.
- Pregnant women who underwent epidural anesthesia or required instrumental delivery
- Pregnant women with a history of chronic cough, urinary incontinence, Anal incontinence, pelvic floor dysfunction, or connective tissue diseases
- Contraindications to vaginal childbirth, such as placenta previa or Placenta accreta spectrum disorder
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 |
|---|---|---|
| Antenatal perineal massageParticipants at 34-35 weeks of gestation were received training in self-perineal massage and performed a daily 5-minute massage using water-based jelly until delivery to compare with standard obstetric care on postpartum morbidities | Other | Antenatal perineal massage |
Primary outcome
Anal incontinence
Time frame: At 3 months post-delivery
To compare anal incontinence between intervention group and control group. Assessed via the validated Thai version of Pelvic Floor Distress Inventory - 20 (PFDI-20)
7 secondary outcomes
Urinary incontinence
Time frame: At 3 months post-delivery
Dyspareunia
Time frame: At 3 months post-delivery
Postpartum pain
Time frame: At 24 hours post-delivery
Duration of each labor stage
Time frame: During delivery
Perineal tears and their degrees
Time frame: During delivery
Episiotomy
Time frame: During delivery
Apgar scores
Time frame: During delivery
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 14 Nov 2024.
- Background: PubMed 33484286Moossdorff-Steinhauser HFA, Berghmans BCM, Spaanderman MEA, Bols EMJ. Urinary incontinence 6 weeks to 1 year post-partum: prevalence, experience of bother, beliefs, and help-seeking behavior. Int Urogynecol J. 2021 Jul;32(7):1817-1824. doi: 10.1007/s00192-020-04644-3. Epub 2021 Jan 23.
- Background: PubMed 34142179Moossdorff-Steinhauser HFA, Berghmans BCM, Spaanderman MEA, Bols EMJ. Prevalence, incidence and bothersomeness of urinary incontinence between 6 weeks and 1 year post-partum: a systematic review and meta-analysis. Int Urogynecol J. 2021 Jul;32(7):1675-1693. doi: 10.1007/s00192-021-04877-w. Epub 2021 Jun 17.
- Background: PubMed 28608597Aasheim V, Nilsen ABV, Reinar LM, Lukasse M. Perineal techniques during the second stage of labour for reducing perineal trauma. Cochrane Database Syst Rev. 2017 Jun 13;6(6):CD006672. doi: 10.1002/14651858.CD006672.pub3.
- Background: PubMed 30941442Dieb AS, Shoab AY, Nabil H, Gabr A, Abdallah AA, Shaban MM, Attia AH. Perineal massage and training reduce perineal trauma in pregnant women older than 35 years: a randomized controlled trial. Int Urogynecol J. 2020 Mar;31(3):613-619. doi: 10.1007/s00192-019-03937-6. Epub 2019 Apr 2.
- Background: PubMed 18751626Mei-dan E, Walfisch A, Raz I, Levy A, Hallak M. Perineal massage during pregnancy: a prospective controlled trial. Isr Med Assoc J. 2008 Jul;10(7):499-502.
- Background: PubMed 20422153Tin RY, Schulz J, Gunn B, Flood C, Rosychuk RJ. The prevalence of anal incontinence in post-partum women following obstetrical anal sphincter injury. Int Urogynecol J. 2010 Aug;21(8):927-32. doi: 10.1007/s00192-010-1134-0. Epub 2010 Apr 27.
- Results publication: PubMed 29607580Ugwu EO, Iferikigwe ES, Obi SN, Eleje GU, Ozumba BC. Effectiveness of antenatal perineal massage in reducing perineal trauma and post-partum morbidities: A randomized controlled trial. J Obstet Gynaecol Res. 2018 Jul;44(7):1252-1258. doi: 10.1111/jog.13640. Epub 2018 Apr 2.
- Results publication: PubMed 35389055Bunyavejchevin S, Ruanphoo P. Thai translation and validation of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) and Pelvic Floor Distress Inventory (PFDI-20). Int Urogynecol J. 2022 Nov;33(11):3137-3142. doi: 10.1007/s00192-022-05148-y. Epub 2022 Apr 7.
- Results publication: PubMed 32399905Abdelhakim AM, Eldesouky E, Elmagd IA, Mohammed A, Farag EA, Mohammed AE, Hamam KM, Hussein AS, Ali AS, Keshta NHA, Hamza M, Samy A, Abdel-Latif AA. Antenatal perineal massage benefits in reducing perineal trauma and postpartum morbidities: a systematic review and meta-analysis of randomized controlled trials. Int Urogynecol J. 2020 Sep;31(9):1735-1745. doi: 10.1007/s00192-020-04302-8. Epub 2020 May 12.
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Childbirth
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antenatal perineal massage in people with Perineum; Injury and Anal Incontinence, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 5 inclusion and 6 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 14 Nov 2024. 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 Thailand. 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?
Anal incontinence (time frame: At 3 months post-delivery). 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 NCT06162312, which also lists 9 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 14 Nov 2024.