NCT02768142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

1.9 years

First QC Date

April 24, 2016

Last Update Submit

August 20, 2019

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin level after delivery

    Difference between pre- and post-surgical hemoglobin levels.

    4 days

Secondary Outcomes (10)

  • Blood product transfusion

    4 days

  • Pain score during the operation

    1 hour

  • Pain score during the first day after cesarean delivery

    24 hours

  • Analgesia use during the operation

    1 hour

  • Analgesia use during the first day after cesarean delivery

    24 hours

  • +5 more secondary outcomes

Study Arms (2)

Natural cesarean delivery

EXPERIMENTAL

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

Other: Natural cesarean delivery

Standard cesarean delivery

ACTIVE COMPARATOR

Presentation of the neonate to the mother during the operation.

Other: Standard cesarean delivery

Interventions

Natural cesarean deliveryOTHER

Natural cesarean delivery

Natural cesarean delivery
Standard cesarean deliveryOTHER

Standard cesarean delivery

Standard cesarean delivery

Eligibility Criteria

Age8 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ob/Gyn, Ha'Emek Medical Center

Afula, Israel

Location

Related Publications (1)

  • 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.

    PMID: 35398585DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Raed Salim, MD

    Emek Medical Center, Afula, Israel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of delivery unit

Study Record Dates

First Submitted

April 24, 2016

First Posted

May 11, 2016

Study Start

August 1, 2016

Primary Completion

July 1, 2018

Study Completion

August 1, 2019

Last Updated

August 22, 2019

Record last verified: 2019-08

Locations

IL(1)