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NCT Number: NCT07771543

Effect of Exercise on Mode of Delivery in Elderly Primigravida With Rigid Perineum

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.

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Key information

Age range

35 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beni-Suef University, Banī Suwayf, Egypt

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About this study

Finally, 60 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. Anonymity of all participants' data was confirmed by coding of all data. Assigning participants to 2 equal groups was conducted by a blinded and an independent research assistant, who randomly allocated participants. Group A (study group) included participants who joined eight weeks of specific therapeutic exercise program and received pieces of advice.9 While, group B involved control participants who followed the routine care and received specific advice as group A participants.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 60 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.

Exclusion criteria

  • 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.

Treatment and study plan

Therapeutic Exercise Program

Other

collection of relaxation exercises and stretching exercises

control group advice

Other

routine antenatal care and advice

Primary outcomes

  1. Mode of Delivery

    Time frame: 3 months

    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.

  2. Pelvic floor muscle tone

    Time frame: 3 months

    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.

Secondary outcomes

  1. Neonate APGAR score

    Time frame: 3 months

    This score was used to assess the neonate's condition during the critical first and fifth minutes of life in neonates of both groups. This score was determined based on evaluating the newborn on five simple criteria; criteria included appearance, pulse, grimace, activity and respiration. The resulting APGAR score ranged from 0 to 10. Scores below 3 were considered critically low, 4-6 as fairly low, and higher than 7 as generally normal.

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Effect of Exercise on Mode of Delivery in Elderly Primigravida With Rigid Perineum: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

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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