The Impact of "Natural" Cesarean Delivery on Peripartum Maternal Blood Loss.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-08-31

Brief Summary

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Throughout the history, the neonate was dependent on maternal touch and care for survival. In modern obstetrics, with hospital care the neonates are seldom separated from their mothers after delivery. Early skin to skin (ESTS) contact after delivery was found to increase milk production, lactation and improve maternal and neonatal outcome.

Oxytocin is the primary hormone responsible for uterine contraction and prevention of postpartum hemorrhage (PPH). ESTS contact increases oxytocin secretion.

The rate of cesarean deliveries (CDs) increased dramatically over the past decades. CD was found to decrease postpartum milk production, postpones early lactation and decreases exclusive breastfeeding.

During the typical CD, the neonate is usually presented for a short while to the mother and breastfeeding is usually delayed at least a number of hours until after the surgery and the recovery period.

Natural CD, enable ESTS contact during the surgery and give the mother the opportunity to start breastfeeding immediately after delivery of the neonate in the surgery suit. Oxytocin secretion increases with ESTS and during breastfeeding.

The aim of this study is to examine blood loss that occurs after Natural CD compared to standard CD without an ESTS contact.

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Detailed Description

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Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Natural cesarean delivery

Placing the neonate on maternal chest immediately after the extraction from the uterus, and permitting breastfeeding during surgery.

Group Type EXPERIMENTAL

Natural cesarean delivery

Intervention Type OTHER

Natural cesarean delivery

Standard cesarean delivery

Presentation of the neonate to the mother during the operation.

Group Type ACTIVE_COMPARATOR

Standard cesarean delivery

Intervention Type OTHER

Standard cesarean delivery

Interventions

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Natural cesarean delivery

Intervention Type OTHER

Standard cesarean delivery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Estimated to be appropriate for gestational age fetus.
* Sonographic dating before 20 weeks of gestation.

Exclusion Criteria

* Non-scheduled CD.
* Major fetal malformations.
* Multiple gestations.
* Non-controlled diabetes.
* Severe pre-eclampsia.
* General anesthesia.
* HIV carrier
* Neonatal need for early resuscitation.

Minimum Eligible Age

8 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No