Delivery; TraumaNCT03287258
Perineal Preparation for Pregnant Ladies.
A study testing 3 program and one program in people with Delivery; Trauma and Pelvic Floor; Perineal Rupture, Obstetric, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. Read more about this study
- Who is it for?
- Ages 35 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delivery; Trauma, Pelvic Floor; Perineal Rupture, Obstetric, Pelvic Floor Muscle Weakness
- What is being tested?
- 3 program and one program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2017to 31 Dec 2017
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women ≥ 35 years old
- Primigravida or multi gravida
Who cannot join
- History of chronic constipation
- History of chronic cough
- Current or past urinary or anal incontinence
- History of genital prolapse before pregnancy
- History of neuromuscular disorders or connective tissue disorders
- History of medical disorders
Show all 9Show fewer
- History of preterm or precipitate labour
- History of premature preterm rupture of membranes.
- Genital infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Perineal Massage and Pelvic Floor Muscle Exercise as an Antenatal Program for Prevention of Perineal Trauma in Elderly Women, a Randomized Controlled Trial.
Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual education program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.
Read the detailed description
Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual educational pelvic floor dysfunction prevention program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.
- Being tested
- 3 program, one program
- Keywords
- perineal massage, health education, perineal tear, episiotomy, pelvic floor muscle exercise
- Medical subject headings
- Wounds and Injuries, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 programOther
The participants will receive 3 programs.The educational pelvic floor dysfunction prevention program, pelvic floor muscle exercise program and perineal massage program will be educated by an investigator during the participant visit 4 weeks before her due date
one programOther
The participants will receive one program. That is the educational pelvic floor dysfunction prevention program.The instructions of the program will be given by an investigator once during the participant visit 4 weeks before her due date.
| Study group | Role | What they receive |
|---|---|---|
| three program | Active comparator | 200 patients are subjected to educational Pelvic floor dysfunction prevention program with perineal massage and Pelvic floor muscle exercise. Receives: Other: 3 program |
| one program | Active comparator | 200 patients are subjected to educational Pelvic floor dysfunction prevention program Receives: Other: one program |
What is being measured
The primary outcome is the main question the study is designed to answer.
perineal tears Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery
Proportion of participants who have perineal tears
Measured: At 15 minutes from delivery
Secondary outcomes (2)
episiotomy need Proportion of participants who need episiotomy at time of delivery will be assessed by an investigator
Proportion of participants who need episiotomy at time of delivery
Measured: At 15 minutes from delivery
Duration of the second stage of labour
Duration of the second stage of labour will be assessed by an investigator
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start25 Apr 2017
- Primary completion20 Jul 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery; TraumaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira S Dieb, Kasr El Aini Hospital
- Investigators
- Amira Dieb, MD, Principal investigator, KasrAlainiH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287258
- Sponsor's protocol ID
- perineal preparation study
- Status last verified
- Oct 2018
- First submitted
- 22 Jul 2017
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Perineal Massage and Pelvic Floor Muscle Exercise as an Antenatal Program for Prevention of Perineal Trauma in Elderly Women, a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03287258
- Acronym / sponsor ID
- perineal preparation study
- Keywords
- perineal massage, health education, perineal tear, episiotomy, pelvic floor muscle exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 25 Apr 2017 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 19 Sep 2017 (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.
Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual education program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.
Detailed description
Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual educational pelvic floor dysfunction prevention program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| three program | Active comparator | Other: 3 program200 patients are subjected to educational Pelvic floor dysfunction prevention program with perineal massage and Pelvic floor muscle exercise. |
| one program | Active comparator | Other: one program200 patients are subjected to educational Pelvic floor dysfunction prevention program |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women ≥ 35 years old
- Primigravida or multi gravida
Key exclusion criteria (9 listed)
- History of chronic constipation
- History of chronic cough
- Current or past urinary or anal incontinence
- History of genital prolapse before pregnancy
- History of neuromuscular disorders or connective tissue disorders
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 |
|---|---|---|
| 3 programThe participants will receive 3 programs.The educational pelvic floor dysfunction prevention program, pelvic floor muscle exercise program and perineal massage program will be educated by an investigator during the participant visit 4 weeks before her due date | Other | three program |
| one programThe participants will receive one program. That is the educational pelvic floor dysfunction prevention program.The instructions of the program will be given by an investigator once during the participant visit 4 weeks before her due date. | Other | one program |
Primary outcome
perineal tears Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery
Time frame: At 15 minutes from delivery
Proportion of participants who have perineal tears
2 secondary outcomes
episiotomy need Proportion of participants who need episiotomy at time of delivery will be assessed by an investigator
Time frame: At 15 minutes from delivery
Duration of the second stage of labour
Time frame: 2 hours
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 2 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Amira Dieb, MD principal investigator
KasrAlainiH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 program and one program in people with Delivery; Trauma and Pelvic Floor; Perineal Rupture, Obstetric, run by Kasr El Aini Hospital at 1 site 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 2 inclusion and 9 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 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
perineal tears Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery (time frame: At 15 minutes from delivery). 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 2 Nov 2018.