ClinicalTrials.gg
CompletedNCT07771543Updated Oct 22, 2026

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

An interventional study of Therapeutic exercise program and control group advice in Pregnancy Complication, sponsored by Beni-Suef University. Completed at 2 sites in Egypt. Open to female participants aged 35 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Apr 2026, registered Aug 2026).
Updated Oct 22, 2026Primary completion movedStudy completion movedGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
35 Years to 40 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 16 studies in Pregnancy Complications with a site in Egypt — 1 open to participants now, 1 under way, none of them phase 3. Pregnancy Complications · Egypt.

Enrollment
7th of 11
60 · median 70
Started
2026
with 1 other
No phase
9 of 16
none open now
Registered
15th of 16
by date
Lead sponsor
6 of 16
Beni-Suef University

Among the 16 studies in Pregnancy Complications with a site in Egypt, this one is the 7th largest by enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2026, is one of 9 with no phase, and was the 15th registered.

Pregnancy Complications

411 studies on the registry are indexed under Pregnancy Complications; 113 are open to participants now.

Browse Pregnancy Complications studies →

Open to participants now

1 of the 16 studies in Pregnancy Complications with a site in Egypt is open now. Recruiting first, the newest first:

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 92 Pregnancy Complications studies recruiting now, 44 (48%) set no upper age limit and 45 (49%) stop at 75 or younger; 22 take children under 18; 35 take healthy volunteers.

This study: 35 Years to 40 Years · female · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies in Pregnancy Complications with a site in Egypt, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Pregnancy Complication
04

Who can participate

Ages eligible
35 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (BMI) did not surpass 30 kg/m2.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Intervention group

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

    Other: control group advice

  • Placebo comparator
    No Intervention

    routine care and received advice

    Other: Therapeutic exercise program

Interventions

  • OtherTherapeutic exercise program

    collection of relaxation exercises and stretching exercises

  • Othercontrol group advice

    routine antenatal care and advice

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

Secondary outcomes

  1. Neonate APGAR score

    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.

    Time frame: 3 months

07

Study locations

2 sites
  • Beni-Suef University
    Banī Suwayf, Egypt
  • Faculty of Physical Therapy- Beni-Suef University
    Banī Suwayf, Egypt
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2026 to primary completion in Oct 2026, 5 months.

Of 119 non-industry interventional studies with no phase under Pregnancy Complications, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 5 months is below that.

Counting every sponsor, half of 119 studies reached it within 26 months; a quarter within 12 and three quarters within 48.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 22, 2026: primary completion Aug 2026 → Oct 2026 and completion Aug 2026 → Oct 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2026
First posted
Aug 18, 2026
StartActual
Apr 15, 2026
Primary completionActual
Oct 11, 2026was Aug 2026
CompletionActual
Oct 12, 2026was Aug 2026
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Aug 8, 2026→Oct 11, 2026
Oct 22, 2026
Study completion
Aug 8, 2026→Oct 12, 2026
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Primary completion Aug 8, 2026→Oct 11, 2026
    Study completion Aug 8, 2026→Oct 12, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07771543
Responsible party
Eman Awad (Associate professor of physical therapy for woman's health, Beni-Suef University) — Principal investigator
First posted
Aug 18, 2026
Start date
Apr 15, 2026
Primary completion
Oct 11, 2026
Completion
Oct 12, 2026
Last update
Oct 22, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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