Urinary Incontinence Clinical Trial
Official title:
Efficacy of Antenatal Perineal Massage in Reducing Postpartum Morbidities
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.
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Rajavithi hospital | Phaya Thai | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Rajavithi Hospital |
Thailand,
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
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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