Efficacy of Antenatal Perineal Massage in Reducing Postpartum Morbidities

Urinary Incontinence Clinical Trial

Official title:

Efficacy of Antenatal Perineal Massage in Reducing Postpartum Morbidities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06162312
• Other study ID #: 182/2566
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anal Incontinence
• Fecal Incontinence
• Perineum; Injury
• Urinary Incontinence

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