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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06162312
Other study ID # 182/2566
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date July 30, 2024

Study information

Verified date December 2023
Source Rajavithi Hospital
Contact Mongkol Koedplangtong, M.D.
Phone 022062900
Email Mongkol.koed@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 106
Est. completion date July 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Intervention

Other:
Antenatal perineal massage
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

Locations

Country Name City State
Thailand Rajavithi hospital Phaya Thai Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (9)

Aasheim 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. — View Citation

Abdelhakim 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 r — View Citation

Bunyavejchevin 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: 1 — View Citation

Dieb 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. — View Citation

Mei-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. — View Citation

Moossdorff-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. — View Citation

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. — View Citation

Tin 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. — View Citation

Ugwu 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.1364 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) At 3 months post-delivery
Secondary 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) At 3 months post-delivery
Secondary Dyspareunia To compare dyspareunia between intervention group and control group. Assessed via the verbal numerical rating scale At 3 months post-delivery
Secondary Postpartum pain To compare postpartum pain between intervention group and control group. Assessed via the verbal numerical rating scale At 24 hours post-delivery
Secondary Duration of each labor stage To compare duration of first, second and third stage of labor stage between intervention group and control group. During delivery
Secondary Perineal tears and their degrees To compare perineal tear occurrences and their degrees between intervention group and control group. During delivery
Secondary Episiotomy To compare episiotomy occurrences between intervention group and control group. During delivery
Secondary Apgar scores To compare Apgar scores at 1 and 5 minutes of the newborns between intervention group and control group. During delivery
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