Pregnancy ComplicationNCT07771543
Effect of Exercise on Mode of Delivery in Elderly Primigravida With Rigid Perineum
A study testing Therapeutic exercise program in people with Pregnancy Complication, run by Beni-Suef University at 2 sites in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 40 years, women only
- Conditions the study is for
- Pregnancy Complication
- What is being tested?
- Therapeutic exercise program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Apr 2026to 12 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Beni-Suef University
Banī Suwayf
Faculty of Physical Therapy- Beni-Suef University
Banī Suwayf
About this study
Official title: Effect of Exercise on Mode of Delivery in Elderly Primigravida With Rigid Perineum: A Randomized Controlled Trial
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.
- Conditions
- Pregnancy Complication
- Being tested
- Therapeutic exercise program, control group advice
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exercise programOther
collection of relaxation exercises and stretching exercises
control group adviceOther
routine antenatal care and advice
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | ten-weeks of specific therapeutic exercise program and received pieces of advice Receives: Other: control group advice |
| No Intervention | Placebo comparator | routine care and received advice Receives: Other: Therapeutic exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start15 Apr 2026
- Primary completion11 Oct 2026
- Study completion12 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Awad, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771543
- Sponsor's protocol ID
- FPTBSUREC/0612/15426
- Status last verified
- Oct 2026
- First submitted
- 8 Aug 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise on Mode of Delivery in Elderly Primigravida With Rigid Perineum: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07771543
- Acronym / sponsor ID
- FPTBSUREC/0612/15426
- Conditions
- Pregnancy Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 11 Oct 2026 (actual)
- Study completion
- 12 Oct 2026 (actual)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: control group adviceten-weeks of specific therapeutic exercise program and received pieces of advice |
| No Intervention | Placebo comparator | Other: Therapeutic exercise programroutine care and received advice |
Who may qualify
- Ages
- 35 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic exercise programcollection of relaxation exercises and stretching exercises | Other | No Intervention |
| control group adviceroutine antenatal care and advice | Other | Intervention group |
Primary outcome
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.
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.
1 secondary outcome
Neonate APGAR score
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
Related trials for Pregnancy Complication
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercise program in people with Pregnancy Complication, run by Beni-Suef University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mode of Delivery (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.