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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07771543
Enrollment
60
Registered
2026-08-18
Start date
2026-04-15
Completion date
2026-08-08
Last updated
2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Complication

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.

Detailed description

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.

Interventions

collection of relaxation exercises and stretching exercises

OTHERcontrol group advice

routine antenatal care and advice

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mode of Delivery3 monthsIt 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.
Pelvic floor muscle tone3 monthsAssessment 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

MeasureTime frameDescription
Neonate APGAR score3 monthsThis 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026