NCT07771543

Brief Summary

Objective of the study is to explore effect of therapeutic exercise program on mode of delivery in elderly primigravida with rigid perineum. women. The main question to be answered by this study: Does a therapeutic exercise program on mode of delivery in elderly primigravida with rigid perineum ? Researchers will compare 2 groups of 70 elderly primigravida women group A (study group) included participants who joined ten-weeks of specific therapeutic exercise program and received pieces of advice. While, group B involved control participants who followed the routine care and received advice as group A participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 18, 2026

Completed
Last Updated

August 18, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 8, 2026

Last Update Submit

August 15, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mode of Delivery

    It included normal vaginal delivery, instrumental vaginal delivery that demanded using of special devices such as forceps or a vacuum extractor to deliver the fetus vaginally, and caesarean delivery.

    3 months

  • Pelvic floor muscle tone

    Assessment of pelvic floor muscle tone was conducted twice before and after 8 weeks of the intervention procedure for all participants by means of vaginal probe of Myo 200 apparatus.

    3 months

Secondary Outcomes (1)

  • Neonate APGAR score

    3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

ten-weeks of specific therapeutic exercise program and received pieces of advice

Other: control group advice

No Intervention

PLACEBO COMPARATOR

routine care and received advice

Other: Therapeutic exercise program

Interventions

collection of relaxation exercises and stretching exercises

No Intervention

routine antenatal care and advice

Intervention group

Eligibility Criteria

Age35 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • elderly primipara women at their 27 -28 weeks' of gestation diagnosed with rigid perineum were enrolled. Their ages ranged from 35-40 years and their body mass index (BMI) did not surpass 30 kg/m2.

You may not qualify if:

  • Participants diagnosed with heart disease, lung disease, incompetent cervix or cervical cerclage, intrauterine fetal growth retardation, hypertension, diabetes mellitus, severe anaemia, thyroid disease, placenta previa, unexplained vaginal bleeding, or active preterm labor, as well as patients with current multiple gestation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beni-Suef University

Banī Suwayf, Egypt

Location

Faculty of Physical Therapy- Beni-Suef University

Banī Suwayf, Egypt

Location

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of physical therapy for woman's health

Study Record Dates

First Submitted

August 8, 2026

First Posted

August 18, 2026

Study Start

April 15, 2026

Primary Completion

August 8, 2026

Study Completion

August 8, 2026

Last Updated

August 18, 2026

Record last verified: 2026-08

Locations