Delivery; Injury, MaternalNCT03108170
Digital Perineal Massage and Pelvic Floor Muscle Exercise During Pregnancy for Prevention of Perineal Laceration
A study testing perineal massage program, Pelvic floor muscle exercise program and Educational pelvic floor dysfunction prevention program in people with Delivery; Injury, Maternal, run by Cairo University 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 only
- Conditions the study is for
- Delivery; Injury, Maternal
- What is being tested?
- perineal massage program, Pelvic floor muscle exercise program and Educational pelvic floor dysfunction prevention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Apr 2017to 25 Dec 2018
- 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
- No healthy volunteers
- 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.
Egypt1 site
Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
Cairo, Greater Cairo, 11956
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.
- Conditions
- Delivery; Injury, Maternal
- Being tested
- perineal massage program, Pelvic floor muscle exercise program, Educational pelvic floor dysfunction prevention program
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perineal massage programOther
The participant will perform digital massage of her perineal area 5 minutes daily starting four weeks before delivery till her actual labour day
Pelvic floor muscle exercise programOther
The participant will perform pelvic floor muscle exercise daily starting four weeks before delivery till her actual labour day
Educational pelvic floor dysfunction prevention programOther
This educational pelvic floor dysfunction prevention program includes instructions about: control of her weight, adequate cleaning for the perineal area, adequate fluid intake, smoking cessation, right posture and frequency of micturition and adequate ingestion of fiber to avoid constipation
| Study group | Role | What they receive |
|---|---|---|
| 3 programs group | Active comparator | 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 duo date Receives: Other: perineal massage program; Other: Pelvic floor muscle exercise program; Other: Educational pelvic floor dysfunction prevention program |
| one program group | Active comparator | 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 duo date. Receives: Other: Educational pelvic floor dysfunction prevention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who have perineal tears
Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery
Measured: At 15 minutes from delivery
Secondary outcomes (2)
Proportion of participants who need episiotomy at time of delivery
Proportion of participants who need episiotomy at time of delivery will be assessed by an investigator
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: At 15 minutes from delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start12 Apr 2017
- Primary completion20 Dec 2018
- Study completion25 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery; Injury, MaternalStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Omran, Cairo University
- Investigators
- Eman Omran, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108170
- Sponsor's protocol ID
- 3644
- Status last verified
- Jul 2020
- First submitted
- 5 Apr 2017
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. 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
- NCT03108170
- Acronym / sponsor ID
- 3644
- Conditions
- Delivery; Injury, Maternal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 25 Dec 2018 (actual)
- First posted
- 11 Apr 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 |
|---|---|---|
| 3 programs group | Active comparator | Other: perineal massage program, Other: Pelvic floor muscle exercise program, Other: Educational pelvic floor dysfunction prevention 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 duo date |
| one program group | Active comparator | Other: Educational pelvic floor dysfunction prevention 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 duo date. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not 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 |
|---|---|---|
| perineal massage programThe participant will perform digital massage of her perineal area 5 minutes daily starting four weeks before delivery till her actual labour day | Other | 3 programs group |
| Pelvic floor muscle exercise programThe participant will perform pelvic floor muscle exercise daily starting four weeks before delivery till her actual labour day | Other | 3 programs group |
| Educational pelvic floor dysfunction prevention programThis educational pelvic floor dysfunction prevention program includes instructions about: control of her weight, adequate cleaning for the perineal area, adequate fluid intake, smoking cessation, right posture and frequency of micturition and adequate ingestion of fiber to avoid constipation | Other | 3 programs group, one program group |
Primary outcome
Proportion of participants who have perineal tears
Time frame: At 15 minutes from delivery
Proportion of perineal tears will be assessed by an investigator who will attend the participant delivery
2 secondary outcomes
Proportion of participants who need episiotomy at time of delivery
Time frame: At 15 minutes from delivery
Duration of the second stage of labour
Time frame: At 15 minutes from delivery
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 15 Jul 2020.
- Individual participant dataSharing planned: Yes
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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.
Eman Omran, M.D. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perineal massage program, Pelvic floor muscle exercise program and Educational pelvic floor dysfunction prevention program in people with Delivery; Injury, Maternal, run by Cairo University 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 15 Jul 2020. 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?
Proportion of participants who have perineal tears (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 15 Jul 2020.