EpisiotomyNCT06625866
Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use
A study testing Feedback and information in people with Episiotomy and Episiotomy Extended by Laceration, run by Universidad Panamericana.
Trial summary
This pilot study seeks to analyze the impact of interventions based on behavioral economics theory (e.g., feedback and information) on episiotomy use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Episiotomy, Episiotomy Extended by Laceration, Episiotomy Infection
- What is being tested?
- Feedback and information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Oct 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthcare personnel involved in decision-making associated with performing episiotomies who work in the hospital selected to pilot the proposed intervention.
Who cannot join
- Healthcare personnel who are not involved in the decision-making process over performing episiotomy during delivery.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Design, Implementation, and Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use: a Pilot Study
This pilot study seeks to analyze the impact of interventions based on behavioral economics theory (e.g., feedback and information) on episiotomy use.
- Being tested
- Feedback and information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback and informationBehavioural
The healthcare professionals in the intervention arm will be exposed to feedback and information behavioral strategies. Namely, interns, residents, obstetricians/gynecologists, and nurses will receive written feedback about the episiotomy rates in the hospital each month during the study period. Moreover, at least two academic sessions will be designed to outline the indications, surgical technique, complications, and surgical ethics for the procedure (i.e., episiotomy). Likewise, each session will also include a patient testimonial about their experience during delivery and their follow-up when an episiotomy was performed.
The feedback intervention will be provided for 2 months, and the feedback intervention + the information intervention will be provided for 2 additional months.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral intervention | Experimental | The healthcare professionals in this hospital will be exposed to behavioral interventions, including feedback and information strategies. Receives: Behavioral: Feedback and information |
| Standard of care | No intervention | The standard of care will be provided in this hospital without exposure to behavioral interventions for healthcare professionals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episiotomies performed
Number of episiotomies performed among patients having a vaginal delivery.
Episiotomy: surgical incision made in the perineum during childbirth to enlarge the vaginal opening and facilitate the delivery.
There are two main types of episiotomies, classified based on the direction of the incision: Median (the incision is made straight down from the vaginal opening towards the anus) and mediolateral (the incision is made at an angle [usually 45 degrees] from the vaginal opening towards the side, away from the anus).
Measured: During spontaneous or assisted vaginal delivery
Secondary outcomes (13)
Episiotomy indication documented in the medical record
Number of episiotomies performed with an indication documented in the medical record among patients having a vaginal delivery.
Potential indications:
Nonreassuring fetal status, prolonged or difficult labor, operative vaginal delivery, shoulder dystocia, large for gestational age fetus, breech delivery, rigid perineum, maternal fatigue or exhaustion, preterm delivery.
Measured: During spontaneous or assisted vaginal delivery
Number of assisted vaginal deliveries
Number of assisted deliveries among patients having a vaginal delivery. Assisted vaginal delivery refers to the use of specialized instruments, such as forceps or a vacuum device, to help guide the fetal head out of the birth canal during childbirth.
Measured: At the time of vaginal delivery
Number of perineal and cervical lacerations (composite outcome)
Number of perineal and cervical lacerations (composite outcome) among patients having a vaginal delivery.
The composite outcome will include any of the following:
Perineal Lacerations:
First degree: Injury to Perineal skin only. Second degree: Injury to perineum involving perineal muscles but not involving anal sphincter. Third degree: Injury to perineum involving anal sphincter complex. 3a: Less than 50% of external anal sphincter thickness torn. 3b: More than 50% external anal sphincter thickness torn. 3c. Both external anal sphincter and internal sphincter torn. Fourth degree: Injury to perineum involving anal sphincter complex (external anal sphincter and internal anal sphincter) and anal epithelium.
Cervical Laceration:
A cervical laceration during delivery refers to a tear or injury to the cervix that occurs during childbirth.
Measured: At the time of spontaneous or assisted vaginal delivery
Rate of transfusion of blood products (composite outcome)
Administration of any of the following :
RBCs, fresh frozen plasma (FFP), platelets and cryoprecipitate
Measured: Administered in the first 24 hours after delivery
Blood loss at the time of delivery
Estimated or calculated blood loss (mL).
Measured: Within the first hour after spontaneous or assisted vaginal delivery
Hematocrit after delivery
Percentage (%) of red blood cells (RBCs) in the total blood volume.
Measured: Within 24 hours after delivery
Pain management after delivery
Description of Nonsteroidal Antiinflammatory Drugs and Opioids administered
Measured: Administered in the first 24 hours after vaginal delivery
Patient satisfaction with the inpatient care received during and after vaginal delivery
Brief voluntary and anonymous survey designed by the research team to be answered by ~300 patients.
Measured: Within the first 24 hours after delivery.
Rate of surgical site infection
Surgical site infection related to episiotomies, perineal, or cervical lacerations that occurred at the site of these surgical or traumatic wounds after childbirth.
Measured: In the first 6 weeks after vaginal delivery
Rate of surgical site dehiscence
Partial or complete wound reopening along a surgical incision or laceration previously closed (e.g., episiotomies, perineal lacerations, cervical lacerations).
Measured: In the first 6 weeks after vaginal delivery
Five-minute Apgar
5-Minute Apgar Score Components:
The Apgar score assesses five key signs of a newborn's health, each assigned a score of 0, 1, or 2, for a total possible score of 10:
- Appearance (skin color)
- 0: Blue or pale all over.
- 1: Body pink, but extremities blue.
- 2: Entire body pink.
- Pulse (heart rate)
- 0: No heartbeat.
- 1: Fewer than 100 beats per minute.
- 2: At least 100 beats per minute.
- Grimace (reflex irritability, response to stimulation)
- 0: No response to stimulation.
- 1: Grimace or weak response when stimulated.
- 2: Strong cry or active withdrawal in response to stimulation.
- Activity (muscle tone)
- 0: Limp, no movement.
- 1: Some flexion of extremities.
- 2: Active movement.
- Respiration (breathing effort)
- 0: Not breathing.
- 1: Weak or irregular breathing.
- 2: Strong cry, normal breathing.
Measured: Neonatal assessment 5 minutes after spontaneous or assisted vaginal delivery
Rate of NICU Admission
Transfer and care of a newborn in the Neonatal Intensive Care Unit (NICU) to provide intensive medical care for premature, ill, or high-risk newborns.
Measured: In the first 24 hours after delivery.
Rate of Neonatal death
Neonatal death refers to the death of a newborn within the first 28 days of life. This period is further divided into two phases:
- Early neonatal death: Neonatal death within the first 7 days of life.
- Late neonatal death: Neonatal death occurring between 7 and 28 days of life.
Measured: Within the first 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpisiotomyStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two hospitals (clusters) will be assigned to intervention and standard of care.
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Panamericana
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de la Salud - UNISA, IMSS-Bienestar, Secretaría de Educación, Ciencia, Tecnología e Innovación de la Ciudad de México
- Responsible party
- Principal investigator, Mario I. Lumbreras-Marquez, MD, MMSc, Universidad Panamericana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625866
- Sponsor's protocol ID
- 101 - 101 - 001 - 24
- Status last verified
- Oct 2024
- First submitted
- 10 Sep 2024
- Last updated
- 3 Oct 2024
- 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 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design, Implementation, and Evaluation of Interventions Based on Behavioral Sciences to Reduce Episiotomy Use: a Pilot Study
- ClinicalTrials.gov ID
- NCT06625866
- Acronym / sponsor ID
- 101 - 101 - 001 - 24
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Universidad PanamericanaUniversity, hospital or other
- Collaborators
- Universidad de la Salud - UNISA, IMSS-Bienestar, Secretaría de Educación, Ciencia, Tecnología e Innovación de la Ciudad de México
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 3 Oct 2024 (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.
This pilot study seeks to analyze the impact of interventions based on behavioral economics theory (e.g., feedback and information) on episiotomy use.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two hospitals (clusters) will be assigned to intervention and standard of care.
| Arm | Type | Receives |
|---|---|---|
| Behavioral intervention | Experimental | Behavioral: Feedback and informationThe healthcare professionals in this hospital will be exposed to behavioral interventions, including feedback and information strategies. |
| Standard of care | No intervention | –The standard of care will be provided in this hospital without exposure to behavioral interventions for healthcare professionals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthcare personnel involved in decision-making associated with performing episiotomies who work in the hospital selected to pilot the proposed intervention.
Key exclusion criteria (1 listed)
- Healthcare personnel who are not involved in the decision-making process over performing episiotomy during delivery.
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 |
|---|---|---|
| Feedback and informationThe healthcare professionals in the intervention arm will be exposed to feedback and information behavioral strategies. Namely, interns, residents, obstetricians/gynecologists, and nurses will receive written feedback about the episiotomy rates in the hospital each month during the study period. Moreover, at least two academic sessions will be designed to outline the indications, surgical technique, complications, and surgical ethics for the procedure (i.e., episiotomy). Likewise, each session will also include a patient testimonial about their experience during delivery and their follow-up when an episiotomy was performed. The feedback intervention will be provided for 2 months, and the feedback intervention + the information intervention will be provided for 2 additional months. | Behavioural | Behavioral intervention |
Primary outcome
Number of episiotomies performed
Time frame: During spontaneous or assisted vaginal delivery
Number of episiotomies performed among patients having a vaginal delivery. Episiotomy: surgical incision made in the perineum during childbirth to enlarge the vaginal opening and facilitate the delivery. There are two main types of episiotomies, classified based on the direction of the incision: Median (the incision is made straight down from the vaginal opening towards the anus) and mediolateral (the incision is made at an angle [usually 45 degrees] from the vaginal opening towards the side, away from the anus).
13 secondary outcomes
Episiotomy indication documented in the medical record
Time frame: During spontaneous or assisted vaginal delivery
Number of assisted vaginal deliveries
Time frame: At the time of vaginal delivery
Number of perineal and cervical lacerations (composite outcome)
Time frame: At the time of spontaneous or assisted vaginal delivery
Rate of transfusion of blood products (composite outcome)
Time frame: Administered in the first 24 hours after delivery
Blood loss at the time of delivery
Time frame: Within the first hour after spontaneous or assisted vaginal delivery
Hematocrit after delivery
Time frame: Within 24 hours after delivery
Pain management after delivery
Time frame: Administered in the first 24 hours after vaginal delivery
Patient satisfaction with the inpatient care received during and after vaginal delivery
Time frame: Within the first 24 hours after delivery.
Rate of surgical site infection
Time frame: In the first 6 weeks after vaginal delivery
Rate of surgical site dehiscence
Time frame: In the first 6 weeks after vaginal delivery
Five-minute Apgar
Time frame: Neonatal assessment 5 minutes after spontaneous or assisted vaginal delivery
Rate of NICU Admission
Time frame: In the first 24 hours after delivery.
Rate of Neonatal death
Time frame: Within the first 28 days of life
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 3 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Episiotomy
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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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Recruiting
Impact of Early Physiotherapy on Pain, Quality of Life, Pelvic Floor Function, and Sexual Health Post-Episiotomy
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Repeated Pudendal Nerve Block and Physiotherapy for Prevention of Chronic Post-Episiotomy Pain
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback and information in people with Episiotomy and Episiotomy Extended by Laceration, run by Universidad Panamericana.
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: opening soon, as of the sponsor's last update on 3 Oct 2024. 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. 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?
Contact Mario I Lumbreras-Marquez, MD, MMSc (+52 55 54821600 ext. 5695, mlumbreras@up.edu.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of episiotomies performed (time frame: During spontaneous or assisted vaginal 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 3 Oct 2024.