Episiotomy Extended by LacerationNCT07374497
Effect of Perineal Massage on the Frequency of Episiotomy and Perineal Tearing
A study testing Intrapartum perineal massage in people with Episiotomy Extended by Laceration, run by Sheikh Zayed Medical College at 1 site in Pakistan.
Trial summary
A randomized controlled trial was conducted at the Department of Obstetrics and Gynaecology, Sheikh Zayed Hospital, Rahim Yar Khan, over 6 months following Institutional Review Board and College of Physicians and Surgeons Pakistan approval, to assess whether intrapartum perineal massage reduces mediolateral episiotomy… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Episiotomy Extended by Laceration
- What is being tested?
- Intrapartum perineal massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Sep 2025to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-45 years
- Primigravida and multigravida women in active labor.
- Singleton, cephalic presentation of the fetus.
- Women who provide informed consent to participate in the study.
- Women at Term pregnancy (37 - 42 weeks).
Who cannot join
- Women with placental abruption, vaginal bleeding, macrosomia, fetal distress, vaginal infections, placenta previa and preterm births.
- Non-vertex fetal presentations such as breech.
- Women scheduled for a cesarean section.
- Pregnancies with multiple gestations (e.g., twins, triplets).
- Presence of active genital herpes or other contraindications to vaginal birth (HIV).
- Active vaginal infections, including bacterial vaginosis or yeast infections.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sheikh Zayed Medical college/hospital
Rahim Yar Khan, Punjab Province, 75000
About this study
A randomized controlled trial was conducted at the Department of Obstetrics and Gynaecology, Sheikh Zayed Hospital, Rahim Yar Khan, over 6 months following Institutional Review Board and College of Physicians and Surgeons Pakistan approval, to assess whether intrapartum perineal massage reduces mediolateral episiotomy and lowers the frequency and severity of perineal tears in women undergoing term (37-42 weeks), singleton, cephalic vaginal delivery. Women aged 18-45 years in active labour who provided written informed consent were consecutively enrolled and randomized (1:1) by a computer-generated sequence with sequentially numbered, opaque, sealed envelopes to either standard intrapartum care or standard care plus perineal massage; women with conditions requiring urgent delivery/caesarean section or contraindicating vaginal delivery/perineal manipulation were excluded. In the intervention arm, a trained doctor performed standardized perineal massage using sterile water-based lubricant during the first stage and again near the second stage, with predefined stopping criteria for safety; the control arm received routine care without massage beyond usual perineal support at delivery. Primary outcomes were episiotomy (Yes/No) and perineal tear occurrence and grade (first-fourth), assessed immediately post-delivery by a consultant obstetrician not involved in providing massage.
- Conditions
- Episiotomy Extended by Laceration
- Being tested
- Intrapartum perineal massage, Standard Intrapartum Care Group (Control)
- Keywords
- Perineal massage, Vaginal delivery, Episiotomy, Perineal laceration, Perineal tear, Obstetric perineal injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrapartum perineal massageProcedure or surgery
Standardized technique with gloved hands and water-based lubricant; thumbs introduced ~2-3 cm into the vagina with steady lateral pressure to vaginal side walls during resting intervals, delivered as 10-minute sessions repeated during first stage of labour, with an additional session near second stage; discontinued if bleeding, severe pain, suspected infection, non-reassuring fetal status, or urgent obstetric indication arose.
Standard Intrapartum Care Group (Control)Other
Women received routine intrapartum care only, with no perineal stretching or massage manoeuvres beyond routine perineal support during delivery, as per hospital protocols.
| Study group | Role | What they receive |
|---|---|---|
| Intrapartum Perineal Massage Group | Experimental | Women received routine intrapartum care plus standardized intrapartum perineal massage performed by a trained doctor during the first stage of labour (repeated sessions) and an additional session as the second stage approached, using a sterile water-based obstetric lubricant. Receives: Procedure: Intrapartum perineal massage |
| Control Group | Placebo comparator | Standard Intrapartum Care Receives: Other: Standard Intrapartum Care Group (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of episiotomy
Proportion of participants in whom a mediolateral episiotomy was performed during vaginal delivery, based on predefined clinical indications and documented by the consultant obstetrician.
Measured: Immediately at the time of delivery (during second stage and recorded immediately after birth)
Frequency of perineal tears
Proportion of participants with any spontaneous perineal laceration after vaginal delivery, determined on systematic post-delivery perineal and vaginal examination by the consultant obstetrician.
Measured: Immediately after birth (post-delivery examination in the labour room)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start10 Sep 2025
- Primary completion10 Feb 2026 (estimated)
- Study completion10 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episiotomy Extended by LacerationStudies 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
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kainat usman, Sheikh Zayed Medical College
- Investigators
- Sumbal Amjad, Principal investigator, Sheikh Zayed Medical college/Hospital, Rahimyar Khan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374497
- Sponsor's protocol ID
- Sheikh ZMC/H4
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 28 Jan 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 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perineal Massage on the Frequency of Episiotomy and Perineal Tearing
- ClinicalTrials.gov ID
- NCT07374497
- Acronym / sponsor ID
- Sheikh ZMC/H4
- Conditions
- Episiotomy Extended by Laceration
- Keywords
- Perineal massage, Vaginal delivery, Episiotomy, Perineal laceration, Perineal tear, Obstetric perineal injury
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 28 Jan 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.
A randomized controlled trial was conducted at the Department of Obstetrics and Gynaecology, Sheikh Zayed Hospital, Rahim Yar Khan, over 6 months following Institutional Review Board and College of Physicians and Surgeons Pakistan approval, to assess whether intrapartum perineal massage reduces mediolateral episiotomy and lowers the frequency and severity of perineal tears in women undergoing term (37-42 weeks), singleton, cephalic vaginal delivery. Women aged 18-45 years in active labour who provided written informed consent were consecutively enrolled and randomized (1:1) by a computer-generated sequence with sequentially numbered, opaque, sealed envelopes to either standard intrapartum care or standard care plus perineal massage; women with conditions requiring urgent delivery/caesarean section or contraindicating vaginal delivery/perineal manipulation were excluded. In the intervention arm, a trained doctor performed standardized perineal massage using sterile water-based lubricant during the first stage and again near the second stage, with predefined stopping criteria for safety; the control arm received routine care without massage beyond usual perineal support at delivery. Primary outcomes were episiotomy (Yes/No) and perineal tear occurrence and grade (first-fourth), assessed immediately post-delivery by a consultant obstetrician not involved in providing massage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrapartum Perineal Massage Group | Experimental | Procedure: Intrapartum perineal massageWomen received routine intrapartum care plus standardized intrapartum perineal massage performed by a trained doctor during the first stage of labour (repeated sessions) and an additional session as the second stage approached, using a sterile water-based obstetric lubricant. |
| Control Group | Placebo comparator | Other: Standard Intrapartum Care Group (Control)Standard Intrapartum Care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients aged 18-45 years
- Primigravida and multigravida women in active labor.
- Singleton, cephalic presentation of the fetus.
- Women who provide informed consent to participate in the study.
- Women at Term pregnancy (37 - 42 weeks).
Key exclusion criteria (6 listed)
- Women with placental abruption, vaginal bleeding, macrosomia, fetal distress, vaginal infections, placenta previa and preterm births.
- Non-vertex fetal presentations such as breech.
- Women scheduled for a cesarean section.
- Pregnancies with multiple gestations (e.g., twins, triplets).
- Presence of active genital herpes or other contraindications to vaginal birth (HIV).
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 |
|---|---|---|
| Intrapartum perineal massageStandardized technique with gloved hands and water-based lubricant; thumbs introduced ~2-3 cm into the vagina with steady lateral pressure to vaginal side walls during resting intervals, delivered as 10-minute sessions repeated during first stage of labour, with an additional session near second stage; discontinued if bleeding, severe pain, suspected infection, non-reassuring fetal status, or urgent obstetric indication arose. | Procedure or surgery | Intrapartum Perineal Massage Group |
| Standard Intrapartum Care Group (Control)Women received routine intrapartum care only, with no perineal stretching or massage manoeuvres beyond routine perineal support during delivery, as per hospital protocols. | Other | Control Group |
Primary outcome
Frequency of episiotomy
Time frame: Immediately at the time of delivery (during second stage and recorded immediately after birth)
Proportion of participants in whom a mediolateral episiotomy was performed during vaginal delivery, based on predefined clinical indications and documented by the consultant obstetrician.
Frequency of perineal tears
Time frame: Immediately after birth (post-delivery examination in the labour room)
Proportion of participants with any spontaneous perineal laceration after vaginal delivery, determined on systematic post-delivery perineal and vaginal examination by the consultant obstetrician.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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.
Sumbal Amjad principal investigator
Sheikh Zayed Medical college/Hospital, Rahimyar Khan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrapartum perineal massage in people with Episiotomy Extended by Laceration, run by Sheikh Zayed Medical College at 1 site in Pakistan.
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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2026. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Frequency of episiotomy (time frame: Immediately at the time of delivery (during second stage and recorded immediately after birth)). 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 28 Jan 2026.