Skip to main content
OpenTrials
Completed

NCT Number: NCT03287258

Perineal Preparation for Pregnant Ladies.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Delivery; Trauma Adherence Interventions Behavior Health Behavior Health Education Medication Adherence Patient Acceptance of Health Care Patient Compliance Pelvic Floor Muscle Weakness Pelvic Floor; Perineal Rupture, Obstetric Treatment Adherence and Compliance Wounds and Injuries

Age range

35 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

KasralainiH

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: Yes

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

3 program

Other

The participants will receive 3 programs.The educational pelvic floor dysfunction prevention program, pelvic floor muscle exercise program and perineal massage program will be educated by an investigator during the participant visit 4 weeks before her due date

one program

Other

The participants will receive one program. That is the educational pelvic floor dysfunction prevention program.The instructions of the program will be given by an investigator once during the participant visit 4 weeks before her due date.

Primary outcomes

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

    Time frame: At 15 minutes from delivery

    Proportion of participants who have perineal tears

Secondary outcomes

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

    Time frame: At 15 minutes from delivery

    Proportion of participants who need episiotomy at time of delivery

  2. Duration of the second stage of labour

    Time frame: 2 hours

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

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

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
2017
Study completion
2017
First posted
Sep 19, 2017
Registry last updated
Nov 2, 2018

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.