Maternal Outcomes Following Manual Lysis of the Placenta.

February 12, 2020 updated by: HaEmek Medical Center, Israel

Maternal Outcomes Following Manual Lysis of the Placenta After Fifteen Compared to Thirty Minutes. A Randomized Controlled Trial.

Comparison of maternal outcomes following manual lysis of placenta 15 vs 30 minutes after delivery. A primary outcome of the drop in hemoglobin will be compared between the two groups. Secondary outcomes include maternal satisfaction, time to first breastfeeding, length of hospital stay, infection rate etc.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Women undergoing spontaneous term vaginal delivery with epidural analgesia will be randomly assigned into one of two groups: 1. manual lysis of placenta 15 minutes after delivery. 2. waiting 30 minutes and then manual lysis of placenta. Both groups will be managed actively during the 3rd stage of delivery, including oxytocin administration and controlled cord traction. Women who develop active bleeding will be promptly treated with manual lysis and excluded from the study. Manual lysis will be performed under epidural analgesia, and prophylactic antibiotics will be administered. Primary outcome of comparison between the two groups: hemoglobin drop after delivery. Secondary outcomes include: maternal satisfaction, time to first breastfeeding, length of hospital stay, infection rate etc.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel
        • Haemek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Term spontaneous vaginal delivery.
  • Singleton Pregnancy.
  • Epidural Analgesia during delivery.
  • Age between 18 and 45 years.

Exclusion Criteria:

  • Active bleeding after delivery that warrants prompt removal of placenta regardless of time from delivery.
  • Vacuum Extraction.
  • Intrapartum Infection.
  • Intrapartum fever above 38 degrees celsius.
  • Wide 3rd and 4th degree perineal tears that mandate suturing under general anaesthesia.
  • Thalassemia Carriers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Manual Lysis after 15 minutes (Intervention)
Manual Lysis of Placenta 15 minutes after Delivery.
Procedure: Manual Lysis of Placenta after 15 minutes (Intervention)
Manual Lysis of Placenta after 15 minutes: We administer prophylactic antibiotics, under epidural analgesia, under aseptic conditions, we perform manual lysis of placenta by introducing the hand through the vagina to the uterine cavity, separating and removing the placenta.
Other Names:
  • Manual Lysis of Placenta after 15 minutes
ACTIVE_COMPARATOR: Manual lysis after 30 minutes (Control)
Waiting 30 minutes after delivery and then manual lysis of the placenta.
Procedure: Manual Lysis of Placenta after 30 minutes (Control)
Manual Lysis of Placenta after 30 minutes: We administer prophylactic antibiotics, under epidural analgesia, under aseptic conditions, we perform manual lysis of placenta by introducing the hand through the vagina to the uterine cavity, separating and removing the placenta.
Other Names:
  • Manual Lysis of Placenta after 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin Drop
Time Frame: within 24 hours after delivery
The difference between Hemoglobin levels before and after delivery
within 24 hours after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Blood Products Given
Time Frame: 7 days
Number and type of blood products given peripartum
7 days
Blood Loss
Time Frame: 7 days
Calculation of estimated blood loss during delivery by accepted formulas
7 days
Febrile morbidity
Time Frame: within one week of delivery
Rate of developing fever after delivery
within one week of delivery
First Nursing
Time Frame: 7 days
Time until first breastfeeding
7 days
Hospital Stay
Time Frame: 7 days
Length of Hospital stay in days
7 days
Maternal Satisfaction
Time Frame: 7 days
Level of maternal satisfaction from the delivery process and interventions as evaluated by a numerical scale from 1 to 5 with 5 being highly satisfied
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Study Chair: Raed Salim, M.D., HaEmek Medical Center, Afula, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 20, 2018

Primary Completion (ANTICIPATED)

September 1, 2020

Study Completion (ANTICIPATED)

September 1, 2020

Study Registration Dates

First Submitted

August 8, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (ACTUAL)

August 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0022-18EMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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