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OpenTrials
Completed

NCT Number: NCT02768142

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

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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Key information

Age range

8 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ob/Gyn, Ha'Emek Medical Center

Afula, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Natural cesarean delivery

Other

Natural cesarean delivery

Standard cesarean delivery

Other

Standard cesarean delivery

Primary outcomes

  1. Hemoglobin level after delivery

    Time frame: 4 days

    Difference between pre- and post-surgical hemoglobin levels.

Secondary outcomes

  1. Blood product transfusion

    Time frame: 4 days

    Number of Packed red blood cells and plasma products

  2. Pain score during the operation

    Time frame: 1 hour

  3. Pain score during the first day after cesarean delivery

    Time frame: 24 hours

    Use of analgesic drugs

  4. Analgesia use during the operation

    Time frame: 1 hour

    Use of analgesic drugs

  5. Analgesia use during the first day after cesarean delivery

    Time frame: 24 hours

  6. Rate of breastfeeding at maternal hospital discharge

    Time frame: 4 days

  7. Rate of breastfeeding 6 months after delivery

    Time frame: 6 months

  8. Maternal satisfaction of the delivery

    Time frame: 4 days

    Satisfaction scale

  9. Breast engorgement

    Time frame: 4 days

    Diagnosed by physical examination

  10. Neonatal temperature after delivery

    Time frame: 1 hour

    Temperature

Sponsors and collaborators

Lead sponsor

Raed Salim

Other

Registry information

Official study title

The Impact of "Natural" Cesarean Delivery on Peripartum Maternal Blood Loss. A Randomized Controlled Trial.

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
May 11, 2016
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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