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Completed

NCT Number: NCT03108170

Digital Perineal Massage and Pelvic Floor Muscle Exercise During Pregnancy for Prevention of Perineal Laceration

Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual education program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.

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Key information

Conditions

Delivery; Injury, Maternal Wounds and Injuries

Age range

35 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Cairo, Greater Cairo, 11956, Egypt

About this study

Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual educational pelvic floor dysfunction prevention program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women ≥ 35 years old
  • Primigravida or multi gravida

Exclusion criteria

  • History of chronic constipation
  • History of chronic cough
  • Current or past urinary or anal incontinence
  • History of genital prolapse before pregnancy
  • History of neuromuscular disorders or connective tissue disorders
  • History of medical disorders
  • History of preterm or precipitate labour
  • History of premature preterm rupture of membranes.
  • Genital infections

Treatment and study plan

perineal massage program

Other

The participant will perform digital massage of her perineal area 5 minutes daily starting four weeks before delivery till her actual labour day

Pelvic floor muscle exercise program

Other

The participant will perform pelvic floor muscle exercise daily starting four weeks before delivery till her actual labour day

Educational pelvic floor dysfunction prevention program

Other

This educational pelvic floor dysfunction prevention program includes instructions about: control of her weight, adequate cleaning for the perineal area, adequate fluid intake, smoking cessation, right posture and frequency of micturition and adequate ingestion of fiber to avoid constipation

Primary outcomes

  1. Proportion of participants who have perineal tears

    Time frame: At 15 minutes from delivery

    Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery

Secondary outcomes

  1. Proportion of participants who need episiotomy at time of delivery

    Time frame: At 15 minutes from delivery

    Proportion of participants who need episiotomy at time of delivery will be assessed by an investigator

  2. Duration of the second stage of labour

    Time frame: At 15 minutes from delivery

    Duration of the second stage of labour will be assessed by an investigator

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Digital Perineal Massage and Pelvic Floor Muscle Exercise as an Antenatal Program for Prevention of Perineal Trauma in Elderly Women, a Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 11, 2017
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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