Comparison of Never Performing Episiotomy to Performing it in a Selective Manor

NCT02178111 | Completed Phase 4 DMC

• 1 other identifier: EPISIO
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

Brief Summary

The study hypothesis is that not performing never episiotomies is safe and results are equivalent to performing episiotomies ina selective manor.

Conditions

Need of Episiotomy

Keywords

episiotomy, vaginal delivery, randomized, perineum

Outcome Measures

Primary Outcomes (8)

• duration of the second stage of labor

  Time in minutes from beginning of second stage of labor until the delivery of the baby

  From beginning of second stage of labor to delivery of the baby

• frequency of episiotomy

  Frequency of episiotomies in fact carried out

  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)

  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

  from delivery to one hour postpartum

• perineal need of suturing

  Perineal suturing carried out by the birth attendant

  From delivery to one hour postpartum

• Apgar scores

  one and five minutes Apgar scores

  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

  From delivery to one hour after delivery

• cord blood pH at birth

  Cord blood pH ( hydrogen ion concentration) at birth collected just after delivery

  From birth of the baby until first minute after delivery

Secondary Outcomes (4)

• frequency of severe perineal trauma

  from delivery of the baby until one hour after delivery

• complications of perineal suture

  From delivery until 15 days after delivery

• perineal pain after childbirth

  From 24 hours after delivery until 48 hours of the delivery

• admission of the newborn (NB) in the neonatal intensive care unit (ICU).

  from delivery until 28 days after birth

Study Arms (2)

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

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)

Procedure: episiotomy

Interventions

Never perform episiotomy OTHER

In this group birth attendants will be sought to avoid at all cost episiotomy. The intention is to never perform episiotomy in this group.

Never perform episiotomy

episiotomy PROCEDURE

Selective episiotomy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women in active labor admitted to the maternity ward
• Term pregnancy (37-42 weeks gestation);
• Maximum Dilation 8cm;
• Live fetus in vertex position.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Materno Infantil Prof. Fernando Figueira: lead

Study Sites (1)

IMIP

Recife, Pernambuco, 50070-550, Brazil

Location

Related Publications (2)

• 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.

  PMID: 28438209 DERIVED

• Melo 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.

  PMID: 25124938 DERIVED

MeSH Terms

Interventions

Episiotomy

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Maria Inês Melo, MS

  IMIP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: June 30, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 17, 2016

Record last verified: 2016-11

Locations

BR (1)