Perineal TraumaNCT07641543
Papaverine for Prevention of Perineal Trauma
A study testing Papaverine Hydrochloride in people with Perineal Trauma and Obstetric Anal Sphincter Injury, run by Dr Raneen Abu Shqara.
Trial summary
Perineal trauma is a common complication of vaginal delivery, particularly among primiparous patients, and may result in short- and long-term maternal morbidity, including pain, dyspareunia, and pelvic floor dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Perineal Trauma, Obstetric Anal Sphincter Injury
- What is being tested?
- Papaverine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 412 participants
- Where
- No sites listed yet
- Study dates
- 3 Jun 2026to 3 Jun 2027
- 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
- Primiparous patients aged 18 years or older
- Singleton pregnancy
- Term pregnancy (37+0 to 42+0 weeks of gestation)
- Cephalic presentation
- Undergoing labor with at least with 2 cm cervical dilatation.
- Ability to provide written informed consent
Who cannot join
- Multiple gestation
- Major fetal congenital anomalies
- Contraindication to vaginal delivery
- Known hypersensitivity or allergy to papaverine hydrochloride
- Known supraventricular tachycardia (SVT)
- Maternal tachycardia (heart rate >100 bpm) or clinically significant cardiac arrhythmia
Show all 10Show fewer
- Known liver disease or hepatic dysfunction
- Active psychiatric condition impairing the ability to provide informed consent
- Inability to provide written informed consent
- Planned cesarean delivery
About this study
Official title: The Impact of Intrapartum Papaverine 80 mg on Perineal Trauma Among Primiparous Women: a Prospective Randomized Double-blind Study.
Perineal trauma is a common complication of vaginal delivery, particularly among primiparous patients, and may result in short- and long-term maternal morbidity, including pain, dyspareunia, and pelvic floor dysfunction. Papaverine hydrochloride, a smooth muscle relaxant with vasodilatory properties, has been shown to improve tissue relaxation and has been used safely in obstetric settings.
This prospective randomized double-blind placebo-controlled study aims to evaluate whether intrapartum intravenous papaverine hydrochloride (80 mg), administered at full cervical dilatation, reduces the rate of perineal trauma among primiparous patients undergoing vaginal delivery. Eligible participants will be randomized in a 1:1 ratio to receive either intravenous papaverine hydrochloride or placebo (normal saline). Maternal, obstetric, and neonatal outcomes, including the rate and severity of perineal trauma, obstetric anal sphincter injuries (OASIS), postpartum hemorrhage, and neonatal outcomes, will be assessed.
Read the detailed description
Perineal trauma is a frequent complication of vaginal birth and is particularly common among primiparous patients. Rates of second-degree perineal tears among nulliparous women have been reported to range between 35% and 78%, while obstetric anal sphincter injuries (OASIS) occur in approximately 0.7% to 2% of vaginal deliveries. Perineal trauma may result in substantial maternal morbidity, including postpartum pain, dyspareunia, pelvic floor dysfunction, urinary or anal incontinence, and impaired quality of life.
Several intrapartum interventions have been investigated to improve perineal tissue elasticity and reduce birth-related trauma, including warm perineal compresses, perineal massage, and active perineal protection techniques. However, pharmacological approaches aimed at enhancing tissue relaxation during labor remain poorly studied.
Papaverine hydrochloride is a smooth muscle relaxant with vasodilatory properties that acts directly on smooth muscle fibers. In obstetric settings, papaverine has been associated with improved cervical ripening and shorter labor duration without significant maternal or neonatal adverse effects. Due to its pharmacological effects on tissue relaxation and vascular perfusion, papaverine may potentially reduce resistance of the perineal tissues during childbirth and consequently decrease the rate and severity of perineal trauma.
Retrospective data from the investigators' institution, including 4,939 primiparous patients, demonstrated lower rates of first- and second-degree perineal tears among women who received intrapartum papaverine. However, because of the retrospective nature of these findings, causal conclusions cannot be established, and prospective randomized evaluation is warranted.
The objective of the present study is to determine whether intravenous papaverine hydrochloride (80 mg), administered at full cervical dilatation, reduces the rate of perineal trauma among primiparous patients undergoing vaginal delivery.
This study is designed as a prospective, randomized, double-blind, placebo-controlled trial. Eligible participants will be randomized in a 1:1 ratio to receive either intravenous papaverine hydrochloride (80 mg diluted in 100 mL normal saline) or placebo (100 mL normal saline) following complete cervical dilatation. Participants, treating physicians, and outcome assessors will remain blinded to treatment allocation.
The primary outcome will be the rate of perineal trauma requiring suturing following vaginal delivery. Secondary outcomes will include the rate of OASIS, episiotomy, mode of delivery, postpartum hemorrhage, manual placental removal, maternal adverse effects, and neonatal outcomes including birthweight, 5-minute Apgar score, umbilical cord pH, and neonatal intensive care unit admission
- Conditions
- Perineal Trauma, Obstetric Anal Sphincter Injury
- Being tested
- Papaverine Hydrochloride, Placebo
- Keywords
- Papaverine, Perineal Trauma, Labor, Vaginal Delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Papaverine HydrochlorideDrug
Intravenous papaverine hydrochloride 80 mg diluted in 100 mL normal saline administered at full cervical dilatation during labor. The study medication will be administered following complete cervical dilatation and prior to delivery in primiparous patients undergoing vaginal birth.
PlaceboDrug
Placebo consisting of 100 mL normal saline administered intravenously at full cervical dilatation during labor. The placebo solution will be prepared in an identical manner to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Papaverine Group | Experimental | Participants randomized to this arm will receive intravenous papaverine hydrochloride 80 mg diluted in 100 mL normal saline administered at full cervical dilatation during labor. Receives: Drug: Papaverine Hydrochloride |
| Placebo Group | Placebo comparator | Participants randomized to this arm will receive placebo consisting of 100 mL normal saline administered intravenously at full cervical dilatation during labor. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Perineal Trauma Requiring Suturing
The rate of perineal trauma requiring suturing following vaginal delivery, including first-, second-, third-, and fourth-degree perineal tears.
Measured: 1 Day
Secondary outcomes (9)
Rate of Obstetric Anal Sphincter Injuries (OASIS)
Rate of third- and fourth-degree perineal tears diagnosed following vaginal delivery.
Measured: 1 day
Rate of Episiotomy
Rate of mediolateral episiotomy performed during delivery.
Measured: 1 day
Mode of Delivery
Mode of delivery including spontaneous vaginal delivery, operative vaginal delivery, or cesarean delivery.
Measured: 1 day
Postpartum Hemorrhage (PPH)
Rate of postpartum hemorrhage diagnosed following delivery according to institutional criteria.
Measured: 1 day
Manual Placental Removal
Need for manual placental removal following delivery.
Measured: 1 day
Maternal Hemoglobin Drop
Difference between pre-delivery hemoglobin level and the lowest postpartum hemoglobin level measured during hospitalization.
Measured: 1 day
Maternal Adverse Events
Maternal adverse effects including tachycardia, hypotension, nausea, vomiting, headache, and dry mouth following study drug administration.
Measured: 7 days
Neonatal Outcomes
5-Minute Apgar Score
Measured: 1 day
NICU Admission
Need for neonatal intensive care unit admission following birth.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start3 Jun 2026 (estimated)
- Primary completion3 Jun 2027 (estimated)
- Study completion3 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perineal 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
- Model description
- Participants will be randomized in a 1:1 ratio to receive either intravenous papaverine hydrochloride 80 mg diluted in 100 mL normal saline or placebo consisting of 100 mL normal saline at full cervical dilatation. Participants, caregivers, investigators, and outcome assessors will remain blinded to treatment allocation. Outcomes will be compared between the two parallel study arms.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Raneen Abu Shqara
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Dr Raneen Abu Shqara, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641543
- Sponsor's protocol ID
- 0015-26-NHR
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made publicly available due to participant privacy considerations and institutional data protection policies. De-identified data may be available from the principal investigator upon reasonable request and subject to institutional review and approval.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Intrapartum Papaverine 80 mg on Perineal Trauma Among Primiparous Women: a Prospective Randomized Double-blind Study.
- ClinicalTrials.gov ID
- NCT07641543
- Acronym / sponsor ID
- 0015-26-NHR
- Conditions
- Perineal Trauma, Obstetric Anal Sphincter Injury
- Keywords
- Papaverine, Perineal Trauma, Labor, Vaginal Delivery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 412 participants (estimated)
- Lead sponsor
- Dr Raneen Abu ShqaraOther government
- Study start
- 3 Jun 2026 (estimated)
- Primary completion
- 3 Jun 2027 (estimated)
- Study completion
- 3 Jun 2027 (estimated)
- First posted
- 11 Jun 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.
Perineal trauma is a common complication of vaginal delivery, particularly among primiparous patients, and may result in short- and long-term maternal morbidity, including pain, dyspareunia, and pelvic floor dysfunction. Papaverine hydrochloride, a smooth muscle relaxant with vasodilatory properties, has been shown to improve tissue relaxation and has been used safely in obstetric settings.
This prospective randomized double-blind placebo-controlled study aims to evaluate whether intrapartum intravenous papaverine hydrochloride (80 mg), administered at full cervical dilatation, reduces the rate of perineal trauma among primiparous patients undergoing vaginal delivery. Eligible participants will be randomized in a 1:1 ratio to receive either intravenous papaverine hydrochloride or placebo (normal saline). Maternal, obstetric, and neonatal outcomes, including the rate and severity of perineal trauma, obstetric anal sphincter injuries (OASIS), postpartum hemorrhage, and neonatal outcomes, will be assessed.
Detailed description
Perineal trauma is a frequent complication of vaginal birth and is particularly common among primiparous patients. Rates of second-degree perineal tears among nulliparous women have been reported to range between 35% and 78%, while obstetric anal sphincter injuries (OASIS) occur in approximately 0.7% to 2% of vaginal deliveries. Perineal trauma may result in substantial maternal morbidity, including postpartum pain, dyspareunia, pelvic floor dysfunction, urinary or anal incontinence, and impaired quality of life.
Several intrapartum interventions have been investigated to improve perineal tissue elasticity and reduce birth-related trauma, including warm perineal compresses, perineal massage, and active perineal protection techniques. However, pharmacological approaches aimed at enhancing tissue relaxation during labor remain poorly studied.
Papaverine hydrochloride is a smooth muscle relaxant with vasodilatory properties that acts directly on smooth muscle fibers. In obstetric settings, papaverine has been associated with improved cervical ripening and shorter labor duration without significant maternal or neonatal adverse effects. Due to its pharmacological effects on tissue relaxation and vascular perfusion, papaverine may potentially reduce resistance of the perineal tissues during childbirth and consequently decrease the rate and severity of perineal trauma.
Retrospective data from the investigators' institution, including 4,939 primiparous patients, demonstrated lower rates of first- and second-degree perineal tears among women who received intrapartum papaverine. However, because of the retrospective nature of these findings, causal conclusions cannot be established, and prospective randomized evaluation is warranted.
The objective of the present study is to determine whether intravenous papaverine hydrochloride (80 mg), administered at full cervical dilatation, reduces the rate of perineal trauma among primiparous patients undergoing vaginal delivery.
This study is designed as a prospective, randomized, double-blind, placebo-controlled trial. Eligible participants will be randomized in a 1:1 ratio to receive either intravenous papaverine hydrochloride (80 mg diluted in 100 mL normal saline) or placebo (100 mL normal saline) following complete cervical dilatation. Participants, treating physicians, and outcome assessors will remain blinded to treatment allocation.
The primary outcome will be the rate of perineal trauma requiring suturing following vaginal delivery. Secondary outcomes will include the rate of OASIS, episiotomy, mode of delivery, postpartum hemorrhage, manual placental removal, maternal adverse effects, and neonatal outcomes including birthweight, 5-minute Apgar score, umbilical cord pH, and neonatal intensive care unit admission
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either intravenous papaverine hydrochloride 80 mg diluted in 100 mL normal saline or placebo consisting of 100 mL normal saline at full cervical dilatation. Participants, caregivers, investigators, and outcome assessors will remain blinded to treatment allocation. Outcomes will be compared between the two parallel study arms.
| Arm | Type | Receives |
|---|---|---|
| Papaverine Group | Experimental | Drug: Papaverine HydrochlorideParticipants randomized to this arm will receive intravenous papaverine hydrochloride 80 mg diluted in 100 mL normal saline administered at full cervical dilatation during labor. |
| Placebo Group | Placebo comparator | Drug: PlaceboParticipants randomized to this arm will receive placebo consisting of 100 mL normal saline administered intravenously at full cervical dilatation during labor. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Primiparous patients aged 18 years or older
- Singleton pregnancy
- Term pregnancy (37+0 to 42+0 weeks of gestation)
- Cephalic presentation
- Undergoing labor with at least with 2 cm cervical dilatation.
Key exclusion criteria (10 listed)
- Multiple gestation
- Major fetal congenital anomalies
- Contraindication to vaginal delivery
- Known hypersensitivity or allergy to papaverine hydrochloride
- Known supraventricular tachycardia (SVT)
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 |
|---|---|---|
| Papaverine HydrochlorideIntravenous papaverine hydrochloride 80 mg diluted in 100 mL normal saline administered at full cervical dilatation during labor. The study medication will be administered following complete cervical dilatation and prior to delivery in primiparous patients undergoing vaginal birth. | Drug | Papaverine Group |
| PlaceboPlacebo consisting of 100 mL normal saline administered intravenously at full cervical dilatation during labor. The placebo solution will be prepared in an identical manner to maintain blinding. | Drug | Placebo Group |
Primary outcome
Rate of Perineal Trauma Requiring Suturing
Time frame: 1 Day
The rate of perineal trauma requiring suturing following vaginal delivery, including first-, second-, third-, and fourth-degree perineal tears.
9 secondary outcomes
Rate of Obstetric Anal Sphincter Injuries (OASIS)
Time frame: 1 day
Rate of Episiotomy
Time frame: 1 day
Mode of Delivery
Time frame: 1 day
Postpartum Hemorrhage (PPH)
Time frame: 1 day
Manual Placental Removal
Time frame: 1 day
Maternal Hemoglobin Drop
Time frame: 1 day
Maternal Adverse Events
Time frame: 7 days
Neonatal Outcomes
Time frame: 1 day
NICU Admission
Time frame: 7 days
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 11 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made publicly available due to participant privacy considerations and institutional data protection policies. De-identified data may be available from the principal investigator upon reasonable request and subject to institutional review and approval.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Papaverine Hydrochloride in people with Perineal Trauma and Obstetric Anal Sphincter Injury, run by Dr Raneen Abu Shqara.
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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Rate of Perineal Trauma Requiring Suturing (time frame: 1 Day). 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 11 Jun 2026.