Clinical trial NCT02768142: The Impact of "Natural" Cesarean Delivery on Peripartum Maternal Blood Loss.
Official title: The Impact of "Natural" Cesarean Delivery on Peripartum Maternal Blood Loss. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 214
Sex: FEMALE
Minimum age (years): 8
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin level after delivery
timeFrame: 4 days
Secondary outcomes:
measure: Blood product transfusion
timeFrame: 4 days
measure: Pain score during the operation
timeFrame: 1 hour
measure: Pain score during the first day after cesarean delivery
timeFrame: 24 hours
measure: Analgesia use during the operation
timeFrame: 1 hour
measure: Analgesia use during the first day after cesarean delivery
timeFrame: 24 hours
measure: Rate of breastfeeding at maternal hospital discharge
timeFrame: 4 days
measure: Rate of breastfeeding 6 months after delivery
timeFrame: 6 months
measure: Maternal satisfaction of the delivery
timeFrame: 4 days
measure: Breast engorgement
timeFrame: 4 days
measure: Neonatal temperature after delivery
timeFrame: 1 hour
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Department of Ob/Gyn, Ha'Emek Medical Center
Study officials:
affiliation: Emek Medical Center, Afula, Israel
name: Raed Salim, MD
role: STUDY_CHAIR
References:
citation: Zafran N, Garmi G, Abdelgani S, Inbar S, Romano S, Salim R. Impact of "natural" cesarean delivery on peripartum blood loss: a randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Jul;4(4):100642. doi: 10.1016/j.ajogmf.2022.100642. Epub 2022 Apr 8.