Postpartum HemorrhageNCT02768142
The Impact of "Natural" Cesarean Delivery on Peripartum Maternal Blood Loss.
A study testing Natural cesarean delivery and Standard cesarean delivery in people with Postpartum Hemorrhage, run by Raed Salim at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 45 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Natural cesarean delivery and Standard cesarean delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Estimated to be appropriate for gestational age fetus.
- Sonographic dating before 20 weeks of gestation.
Who cannot join
- Non-scheduled CD.
- Major fetal malformations.
- Multiple gestations.
- Non-controlled diabetes.
- Severe pre-eclampsia.
- General anesthesia.
- HIV carrier
- Neonatal need for early resuscitation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of "Natural" Cesarean Delivery on Peripartum Maternal Blood Loss. A Randomized Controlled Trial.
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.
Read more
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.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Natural cesarean delivery, Standard cesarean delivery
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural cesarean deliveryOther
Natural cesarean delivery
Standard cesarean deliveryOther
Standard cesarean delivery
| Study group | Role | What they receive |
|---|---|---|
| Natural cesarean delivery | Experimental | Placing the neonate on maternal chest immediately after the extraction from the uterus, and permitting breastfeeding during surgery. Receives: Other: Natural cesarean delivery |
| Standard cesarean delivery | Active comparator | Presentation of the neonate to the mother during the operation. Receives: Other: Standard cesarean delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin level after delivery
Difference between pre- and post-surgical hemoglobin levels.
Measured: 4 days
Secondary outcomes (10)
Blood product transfusion
Number of Packed red blood cells and plasma products
Measured: 4 days
Pain score during the operation
Measured: 1 hour
Pain score during the first day after cesarean delivery
Use of analgesic drugs
Measured: 24 hours
Analgesia use during the operation
Use of analgesic drugs
Measured: 1 hour
Analgesia use during the first day after cesarean delivery
Measured: 24 hours
Rate of breastfeeding at maternal hospital discharge
Measured: 4 days
Rate of breastfeeding 6 months after delivery
Measured: 6 months
Maternal satisfaction of the delivery
Satisfaction scale
Measured: 4 days
Breast engorgement
Diagnosed by physical examination
Measured: 4 days
Neonatal temperature after delivery
Temperature
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2018
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raed Salim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raed Salim, HaEmek Medical Center, Israel
- Investigators
- Raed Salim, MD, Study chair, Emek Medical Center, Afula, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768142
- Sponsor's protocol ID
- 00137-15-EMC
- Status last verified
- Aug 2019
- First submitted
- 24 Apr 2016
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 35398585
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of "Natural" Cesarean Delivery on Peripartum Maternal Blood Loss. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02768142
- Acronym / sponsor ID
- 00137-15-EMC
- Conditions
- Postpartum Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Raed SalimUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural cesarean delivery | Experimental | Other: Natural cesarean deliveryPlacing the neonate on maternal chest immediately after the extraction from the uterus, and permitting breastfeeding during surgery. |
| Standard cesarean delivery | Active comparator | Other: Standard cesarean deliveryPresentation of the neonate to the mother during the operation. |
Who may qualify
- Ages
- 8 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Estimated to be appropriate for gestational age fetus.
- Sonographic dating before 20 weeks of gestation.
Key exclusion criteria (8 listed)
- Non-scheduled CD.
- Major fetal malformations.
- Multiple gestations.
- Non-controlled diabetes.
- Severe pre-eclampsia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural cesarean deliveryNatural cesarean delivery | Other | Natural cesarean delivery |
| Standard cesarean deliveryStandard cesarean delivery | Other | Standard cesarean delivery |
Primary outcome
Hemoglobin level after delivery
Time frame: 4 days
Difference between pre- and post-surgical hemoglobin levels.
10 secondary outcomes
Blood product transfusion
Time frame: 4 days
Pain score during the operation
Time frame: 1 hour
Pain score during the first day after cesarean delivery
Time frame: 24 hours
Analgesia use during the operation
Time frame: 1 hour
Analgesia use during the first day after cesarean delivery
Time frame: 24 hours
Rate of breastfeeding at maternal hospital discharge
Time frame: 4 days
Rate of breastfeeding 6 months after delivery
Time frame: 6 months
Maternal satisfaction of the delivery
Time frame: 4 days
Breast engorgement
Time frame: 4 days
Neonatal temperature after delivery
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Derived from this study: PubMed 35398585Zafran 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.
- Individual participant dataSharing planned: Undecided
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raed Salim, MD study chair
Emek Medical Center, Afula, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural cesarean delivery and Standard cesarean delivery in people with Postpartum Hemorrhage, run by Raed Salim at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin level after delivery (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02768142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.