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EFFECT OF PELVIC FLOOR MUSCLE TRAINING AMONG PREGNANT BLACK AFRICAN POPULATION ON THE RISK OF POSPARTUM URINARY INCONTINENCE, A SINGLE BLIND RANDOMIZE - Trial PACTR201407000834391

Access comprehensive clinical trial information for PACTR201407000834391 through Pure Global AI's free database. This Not Applicable trial is sponsored by Aga Khan University, East Africa and is currently Not yet recruiting. The study focuses on Pregnancy and Childbirth; Other.

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PACTR201407000834391
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Trial Details
Pan Africa Clinical Trials Registry โ€ข PACTR201407000834391
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EFFECT OF PELVIC FLOOR MUSCLE TRAINING AMONG PREGNANT BLACK AFRICAN POPULATION ON THE RISK OF POSPARTUM URINARY INCONTINENCE, A SINGLE BLIND RANDOMIZE
EFFECT OF PELVIC FLOOR MUSCLE TRAINING AMONG PREGNANT BLACK AFRICAN POPULATION ON THE RISK OF POSPARTUM URINARY INCONTINENCE, A SINGLE BLIND RANDOMIZED CONTROL TRIAL

Study Focus

Sponsor & Location

Aga Khan University, East Africa

Kenya

Timeline & Enrollment

Not Applicable

Jan 01, 1900

Jan 01, 1900

Summary

ABSTRACTBACKGROUNDPelvic Floor Muscle Training (PFMT) in the antenatal period has been found to be an effective primary prevention intervention in the Caucasian population in reducing the incidence of postpartum Urinary Incontinence.OBJECTIVEThis study is primarily designed to determine the effect of PFMT introduced in the second trimester amongst pregnant African population on the incidence of six weeks postpartum Urinary Incontinence.Secondary objectives include investigating the incidence of postpartum Urinary Incontinence, the effect of mode of delivery on incidence of postpartum Urinary Incontinence and determining contributory factors in this population on the incidence of postpartum Urinary Incontinence. STUDY DESIGNThe study will be a single blind Randomized Control Trial. INTERVENTIONPFMT to be conducted by a Physiotherapist and a Continence Nurse from recruitment to 37 completed weeks of gestation, with the control group receiving standard Antenatal care.ASSESSMENT OF URINARY INCONTINENCE STATUSData collection will be done primarily by administering a validated questionnaire (ICIQ-UI Short Form) at recruitment in the Antenatal clinic and in the postpartum period at the six week postnatal visit.DATA ANALYSISIntention to treat analysis will be undertaken using the SPSS Statistics 17.0 software package. The incidence of the 6 week postpartum Urinary Incontinence as a proportion for the treatment and control groups will be determined. Comparison of proportions will be done using the Chi-square test. Pยฟ 0.05 will be considered statistically significant.

ICD-10 Classifications

Pregnancy, childbirth and the puerperium
Fetus and newborn affected by maternal factors and by complications of pregnancy, labour and delivery
Fetus and newborn affected by other complications of labour and delivery
Fetus and newborn affected by other specified complications of labour and delivery
Fetus and newborn affected by other maternal complications of pregnancy

Data Source

Pan Africa Clinical Trials Registry

PACTR201407000834391

Non-Device Trial