Efficacy of Antenatal Perineal Massage in Reducing Postpartum Morbidities

NCT06162312 | Completed DMC

• 1 other identifier: 182/2566
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Perineum; Injury; Anal Incontinence; Urinary Incontinence

Keywords

antenatal perineal massage; postpartum morbidities; Anal Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Urinary incontinence

  At 3 months post-delivery

• Dyspareunia

  At 3 months post-delivery

• Postpartum pain

  At 24 hours post-delivery

• Duration of each labor stage

  During delivery

• Perineal tears and their degrees

  During delivery

Study Arms (2)

Antenatal perineal massage

EXPERIMENTAL

daily 5-minute perineal massage from the 34th or 35th week of pregnancy until delivery

Other: Antenatal perineal massage

Control

NO INTERVENTION

standard antenatal, intrapartum and postpartum care

Interventions

Antenatal perineal massage OTHER

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

Antenatal perineal massage

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi hospital

Phaya Thai, Bangkok, 10400, Thailand

Location

Related Publications (9)

• 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.13640. Epub 2018 Apr 2.

  PMID: 29607580 BACKGROUND

• 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: 10.1007/s00192-022-05148-y. Epub 2022 Apr 7.

  PMID: 35389055 BACKGROUND

• Steiger A, Rupprecht R, Spengler D, Guldner J, Hemmeter U, Rothe B, Damm K, Holsboer F. Functional properties of deoxycorticosterone and spironolactone: molecular characterization and effects on sleep-endocrine activity. J Psychiatr Res. 1993 Jul-Sep;27(3):275-84. doi: 10.1016/0022-3956(93)90038-4.

  PMID: 8295159 BACKGROUND

• Nadkarni TD, Goel A, Shenoy A, Karapurkar AP. Cladosporium bantianum (trichoides) infection of the brain. J Postgrad Med. 1993 Jan-Mar;39(1):43-4.

  PMID: 8295150 BACKGROUND

• Tom BH, Macek CM, Subramanian C, Miller AL, Sengupta J. In vitro expression of suppressogenic and enhancing activities in human colon cancer cells. J Biol Response Mod. 1984 Aug;3(4):435-44.

  PMID: 6481402 BACKGROUND

• 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.

  PMID: 30941442 BACKGROUND

• 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.

  PMID: 18751626 BACKGROUND

• 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 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.

  PMID: 32399905 BACKGROUND

• 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.

  PMID: 20422153 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Encopresis; Urinary Incontinence

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 8, 2023
• Study Start: December 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 30, 2024
• Last Updated: November 14, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)