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NCT03287258

Perineal Preparation for Pregnant Ladies.

Completed NA Last updated 2 November 2018
What this trial tests

NA trial testing 3 program in Delivery; Trauma in 400 participants. Completed in 31 December 2017.

Timeline
25 April 2017
Primary endpoint
20 July 2017
31 December 2017

Quick facts

Lead sponsorKasr El Aini Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment400
Start date25 April 2017
Primary completion20 July 2017
Estimated completion31 December 2017
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Kasr El Aini Hospital

Who can join

Adults 35 to 45, female only, with Delivery; Trauma or Pelvic Floor; Perineal Rupture, Obstetric. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women.
    Woodley SJ, Lawrenson P, Boyle R, Cody JD, et al · · 2020 · cited 163× · PMID 32378735 · DOI 10.1002/14651858.cd007471.pub4

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