Need of EpisiotomyPhase 4EPISIONCT02178111
Comparison of Never Performing Episiotomy to Performing it in a Selective Manor
A Phase 4 study testing Never perform episiotomy and episiotomy in people with Need of Episiotomy, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
Trial summary
The study hypothesis is that not performing never episiotomies is safe and results are equivalent to performing episiotomies ina selective manor. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Need of Episiotomy
- What is being tested?
- Never perform episiotomy and episiotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2014to Sep 2014
- Phase
- Phase 4
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women in active labor admitted to the maternity ward
- Term pregnancy (37-42 weeks gestation);
- Maximum Dilation 8cm;
- Live fetus in vertex position.
Who cannot join
- hemorrhagic syndromes of pregnancy (premature separation of the normally implanted placenta
- Women with an indication for cesarean section: cephalopelvic disproportion (DCP), non reassuring fetal heart rate, dystocia;
- Women without capacity to consent and without legal guardians.
- Women undergoing cesarean delivery (post-randomization exclusion)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Not Performing Episiotomy Versus Selective Episiotomy: a Randomized Clinical Trial
The study hypothesis is that not performing never episiotomies is safe and results are equivalent to performing episiotomies ina selective manor.
Read the detailed description
World Health Organization recommends that the rate of episiotomy in various departments will be around 10%, which is already a reality in many European countries. The episiotomy should be limited and physicians should be encouraged to use their clinical judgment to decide when the procedure is necessary. There are no clinical evidence corroborating any indication of episiotomy, so not yet known whether episiotomy is indeed necessary in any context obstetric practice. Objectives: To compare the maternal and perinatal outcomes in women undergoing a protocol of not conducting episiotomy versus selective episiotomy. Methods: A randomized clinical trial will be conducted in open Maternity Instituto de Medicina Integral Prof. Fernando Figueira, from August 2012 to July 2013. 340 women will be included in labor with term pregnancy, maximum dilation of 8 cm, live fetus in cephalic vertex presentation and will be excluded women with bleeding disorders of pregnancy , indication for caesarean section, women without capacity to consent and without legal guardians. The primary outcomes will be: frequency of episiotomy, delivery duration, frequency of spontaneous lacerations, frequency of instrumental delivery. frequency of perineal trauma, postpartum blood loss, need for perineal suturing, number of sutures, Apgar scores at one and five minutes, need for neonatal resuscitation and pH in cord blood. As secondary outcomes will be assessed: frequency of severe perineal trauma, complications of perineal suturing perineal pain postpartum evaluated according to the visual scale, maternal satisfaction, neonatal morbidity and admission RN in NICU. Women will be invited to participate and those who agree should signing the consent form. At the beginning of the second stage will open the envelope to determine which group included women, with 170 assigned to a protocol of not conducting episiotomy (experimental group) and 170 to a group that episiotomy is performed selectively (Control Group ), according to the judgment of the provider of care delivery. Statistical analysis will be performed using the Epi-Info statistical program 7, adopting the principle of intention to treat. The analysis will be performed with the groups identified as A or B by a blinded statistician to the meaning of the lyrics, breaking the secrecy only after the results obtained and prepared the tables. Categorical variables were compared in contingency tables, using the chi-square test of association and Fisher's exact test, as appropriate. The risk ratio (RR) shall be calculated as measure of relative risk, determining the confidence interval at 95%. Regarding the quantitative variables, if they have normal distribution, comparison between groups will be conducted through the Student's t test for unpaired samples. If it is found that the distribution is not normal, the nonparametric Mann-Whitney-will be used. Ethical aspects, the present study addresses the Resolution 196/96 of the National Health Council and will be submitted to the iMIP Research Ethics Committee, beginning only after your approval. All participants will be included only if they agree to voluntarily participate by signing the consent
- Conditions
- Need of Episiotomy
- Being tested
- Never perform episiotomy, episiotomy
- Keywords
- episiotomy, vaginal delivery, randomized, perineum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Never perform episiotomyOther
In this group birth attendants will be sought to avoid at all cost episiotomy. The intention is to never perform episiotomy in this group.
episiotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Never perform episiotomy | Experimental | In this group the birth attendant will sought to avoid the use of episiotomy, and try not to carry out the procedure unless considered absolutely needed Receives: Other: Never perform episiotomy |
| Selective episiotomy | Active comparator | Patients will be subjected to the usual routine (selective episiotomy, ie, in the presence of indications described in the literature, according to the discretion of the physician or nurse assisting the birth) Receives: Procedure: episiotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of the second stage of labor
Time in minutes from beginning of second stage of labor until the delivery of the baby
Measured: From beginning of second stage of labor to delivery of the baby
frequency of episiotomy
Frequency of episiotomies in fact carried out
Measured: From diagnosis of second stage of labor to delivery of the neonate
frequency of spontaneous lacerations
Frequency of spontaneous lacerations verified immediatly after delivery (time frame from randomization until one hour after delivery)
Measured: From randomizatyion to one hour after delivery
blood loss at delivery
Volume of blood loss in mililiters, lost by the patient from the genital tract, from the moment of the delivery to one hour after delivery
Measured: from delivery to one hour postpartum
perineal need of suturing
Perineal suturing carried out by the birth attendant
Measured: From delivery to one hour postpartum
Apgar scores
one and five minutes Apgar scores
Measured: From delivery to five minutes after delivery
need for neonatal resuscitation
Need of any resuscitation procedures carried out in the conduction of the neonate, from the time of birth until one hour after delivery
Measured: From delivery to one hour after delivery
cord blood pH at birth
Cord blood pH ( hydrogen ion concentration) at birth collected just after delivery
Measured: From birth of the baby until first minute after delivery
Secondary outcomes (4)
frequency of severe perineal trauma
frequency of severe perineal trauma observed by the birth attendant
Measured: from delivery of the baby until one hour after delivery
complications of perineal suture
presence of hematoma, or infection or dehiscence of perineal suture described in the patients records from the moment of the delivery until 15 days after the delivery
Measured: From delivery until 15 days after delivery
perineal pain after childbirth
perineal pain after childbirth evaluated according to the visual scale and maternal satisfaction, the evaluation is carried from 24 to 48 hours after the delivery, before maternal discharge from the hospital
Measured: From 24 hours after delivery until 48 hours of the delivery
admission of the newborn (NB) in the neonatal intensive care unit (ICU).
admission of the newborn (NB) in the neonatal intensive care unit (ICU).
Measured: from delivery until 28 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Need of 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
- Investigators
- Maria Inês Melo, MS, Principal investigator, IMIP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178111
- Sponsor's protocol ID
- EPISIO
- Acronym
- EPISIO
- Status last verified
- Nov 2016
- First submitted
- 16 Jun 2014
- Last updated
- 17 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
M Amorim M, Coutinho IC, Melo I, Katz L. Selective episiotomy vs. implementation of a non-episiotomy protocol: a randomized clinical trial. Reprod Health. 2017 Apr 24;14(1):55. doi: 10.1186/s12978-017-0315-4.
PubMed 28438209Melo I, Katz L, Coutinho I, Amorim MM. Selective episiotomy vs. implementation of a non episiotomy protocol: a randomized clinical trial. Reprod Health. 2014 Aug 14;11:66. doi: 10.1186/1742-4755-11-66.
PubMed 25124938
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Not Performing Episiotomy Versus Selective Episiotomy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02178111
- Acronym / sponsor ID
- EPISIO / EPISIO
- Conditions
- Need of Episiotomy
- Keywords
- episiotomy, vaginal delivery, randomized, perineum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 Jun 2014 (estimated)
- 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.
The study hypothesis is that not performing never episiotomies is safe and results are equivalent to performing episiotomies ina selective manor.
Detailed description
World Health Organization recommends that the rate of episiotomy in various departments will be around 10%, which is already a reality in many European countries. The episiotomy should be limited and physicians should be encouraged to use their clinical judgment to decide when the procedure is necessary. There are no clinical evidence corroborating any indication of episiotomy, so not yet known whether episiotomy is indeed necessary in any context obstetric practice. Objectives: To compare the maternal and perinatal outcomes in women undergoing a protocol of not conducting episiotomy versus selective episiotomy. Methods: A randomized clinical trial will be conducted in open Maternity Instituto de Medicina Integral Prof. Fernando Figueira, from August 2012 to July 2013. 340 women will be included in labor with term pregnancy, maximum dilation of 8 cm, live fetus in cephalic vertex presentation and will be excluded women with bleeding disorders of pregnancy , indication for caesarean section, women without capacity to consent and without legal guardians. The primary outcomes will be: frequency of episiotomy, delivery duration, frequency of spontaneous lacerations, frequency of instrumental delivery. frequency of perineal trauma, postpartum blood loss, need for perineal suturing, number of sutures, Apgar scores at one and five minutes, need for neonatal resuscitation and pH in cord blood. As secondary outcomes will be assessed: frequency of severe perineal trauma, complications of perineal suturing perineal pain postpartum evaluated according to the visual scale, maternal satisfaction, neonatal morbidity and admission RN in NICU. Women will be invited to participate and those who agree should signing the consent form. At the beginning of the second stage will open the envelope to determine which group included women, with 170 assigned to a protocol of not conducting episiotomy (experimental group) and 170 to a group that episiotomy is performed selectively (Control Group ), according to the judgment of the provider of care delivery. Statistical analysis will be performed using the Epi-Info statistical program 7, adopting the principle of intention to treat. The analysis will be performed with the groups identified as A or B by a blinded statistician to the meaning of the lyrics, breaking the secrecy only after the results obtained and prepared the tables. Categorical variables were compared in contingency tables, using the chi-square test of association and Fisher's exact test, as appropriate. The risk ratio (RR) shall be calculated as measure of relative risk, determining the confidence interval at 95%. Regarding the quantitative variables, if they have normal distribution, comparison between groups will be conducted through the Student's t test for unpaired samples. If it is found that the distribution is not normal, the nonparametric Mann-Whitney-will be used. Ethical aspects, the present study addresses the Resolution 196/96 of the National Health Council and will be submitted to the iMIP Research Ethics Committee, beginning only after your approval. All participants will be included only if they agree to voluntarily participate by signing the consent
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Never perform episiotomy | Experimental | Other: Never perform episiotomyIn this group the birth attendant will sought to avoid the use of episiotomy, and try not to carry out the procedure unless considered absolutely needed |
| Selective episiotomy | Active comparator | Procedure: episiotomyPatients will be subjected to the usual routine (selective episiotomy, ie, in the presence of indications described in the literature, according to the discretion of the physician or nurse assisting the birth) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Women in active labor admitted to the maternity ward
- Term pregnancy (37-42 weeks gestation);
- Maximum Dilation 8cm;
- Live fetus in vertex position.
Key exclusion criteria (4 listed)
- hemorrhagic syndromes of pregnancy (premature separation of the normally implanted placenta
- Women with an indication for cesarean section: cephalopelvic disproportion (DCP), non reassuring fetal heart rate, dystocia;
- Women without capacity to consent and without legal guardians.
- Women undergoing cesarean delivery (post-randomization exclusion)
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 |
|---|---|---|
| Never perform episiotomyIn this group birth attendants will be sought to avoid at all cost episiotomy. The intention is to never perform episiotomy in this group. | Other | Never perform episiotomy |
| episiotomy | Procedure or surgery | Selective episiotomy |
Primary outcome
duration of the second stage of labor
Time frame: From beginning of second stage of labor to delivery of the baby
Time in minutes from beginning of second stage of labor until the delivery of the baby
frequency of episiotomy
Time frame: From diagnosis of second stage of labor to delivery of the neonate
Frequency of episiotomies in fact carried out
frequency of spontaneous lacerations
Time frame: From randomizatyion to one hour after delivery
Frequency of spontaneous lacerations verified immediatly after delivery (time frame from randomization until one hour after delivery)
blood loss at delivery
Time frame: from delivery to one hour postpartum
Volume of blood loss in mililiters, lost by the patient from the genital tract, from the moment of the delivery to one hour after delivery
perineal need of suturing
Time frame: From delivery to one hour postpartum
Perineal suturing carried out by the birth attendant
Apgar scores
Time frame: From delivery to five minutes after delivery
one and five minutes Apgar scores
need for neonatal resuscitation
Time frame: From delivery to one hour after delivery
Need of any resuscitation procedures carried out in the conduction of the neonate, from the time of birth until one hour after delivery
cord blood pH at birth
Time frame: From birth of the baby until first minute after delivery
Cord blood pH ( hydrogen ion concentration) at birth collected just after delivery
4 secondary outcomes
frequency of severe perineal trauma
Time frame: from delivery of the baby until one hour after delivery
complications of perineal suture
Time frame: From delivery until 15 days after delivery
perineal pain after childbirth
Time frame: From 24 hours after delivery until 48 hours of the delivery
admission of the newborn (NB) in the neonatal intensive care unit (ICU).
Time frame: from delivery until 28 days after birth
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 17 Nov 2016.
- Derived from this study: PubMed 28438209M Amorim M, Coutinho IC, Melo I, Katz L. Selective episiotomy vs. implementation of a non-episiotomy protocol: a randomized clinical trial. Reprod Health. 2017 Apr 24;14(1):55. doi: 10.1186/s12978-017-0315-4.
- Derived from this study: PubMed 25124938Melo I, Katz L, Coutinho I, Amorim MM. Selective episiotomy vs. implementation of a non episiotomy protocol: a randomized clinical trial. Reprod Health. 2014 Aug 14;11:66. doi: 10.1186/1742-4755-11-66.
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.
Maria Inês Melo, MS principal investigator
IMIP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Never perform episiotomy and episiotomy in people with Need of Episiotomy, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
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 4 inclusion and 4 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 17 Nov 2016. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
duration of the second stage of labor (time frame: From beginning of second stage of labor to delivery of the baby). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02178111, which also lists 2 linked publications.
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 17 Nov 2016.