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Maternal Outcomes Following Manual Lysis of the Placenta.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626844
Recruitment Status : Suspended (Insufficient resources.)
First Posted : August 13, 2018
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Third Stage of Delivery Procedure: Manual Lysis of Placenta after 15 minutes (Intervention) Procedure: Manual Lysis of Placenta after 30 minutes (Control) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Maternal Outcomes Following Manual Lysis of the Placenta After Fifteen Compared to Thirty Minutes. A Randomized Controlled Trial.
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

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 Name: 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 Name: Manual Lysis of Placenta after 30 minutes




Primary Outcome Measures :
  1. Hemoglobin Drop [ Time Frame: within 24 hours after delivery ]
    The difference between Hemoglobin levels before and after delivery


Secondary Outcome Measures :
  1. Rate of Blood Products Given [ Time Frame: 7 days ]
    Number and type of blood products given peripartum

  2. Blood Loss [ Time Frame: 7 days ]
    Calculation of estimated blood loss during delivery by accepted formulas

  3. Febrile morbidity [ Time Frame: within one week of delivery ]
    Rate of developing fever after delivery

  4. First Nursing [ Time Frame: 7 days ]
    Time until first breastfeeding

  5. Hospital Stay [ Time Frame: 7 days ]
    Length of Hospital stay in days

  6. 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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626844


Locations
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Israel
Haemek Medical Center
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Study Chair: Raed Salim, M.D. Haemek Medical Center, Afula, Israel
Publications:

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Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT03626844    
Other Study ID Numbers: 0022-18EMC
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HaEmek Medical Center, Israel:
Manual Lysis, Postpartum Hemorrhage, Third Stage of Delivery.