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NCT Number: NCT03626844

Maternal Outcomes Following Manual Lysis of the Placenta.

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 blood transfusion rate, maternal satisfaction, time to first breastfeeding, length of hospital stay, infection rate etc.

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Key information

Conditions

Third Stage of Delivery Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Haemek Medical Center

Afula, Israel

About this study

Women undergoing spontaneous vaginal delivery at term with epidural analgesia will be randomly assigned to one of two groups: (1) manual removal of the placenta 15 minutes after delivery or (2) expectant management for 30 minutes, followed by manual removal of the placenta if it has not been delivered.

Both groups will receive active management of the third stage of labor, including oxytocin administration. Participants who develop active bleeding will undergo immediate manual removal of the placenta according to standard clinical care. Manual removal will be performed under epidural analgesia, and prophylactic antibiotics will be administered.

The primary outcome will be the difference in postpartum hemoglobin reduction between the two groups. Secondary outcomes will include incidence of blood transfusion, maternal satisfaction, time to first breastfeeding, length of hospital stay, infection rate.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Manual Lysis of Placenta after 15 minutes (Intervention)

Procedure

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

Manual Lysis of Placenta after 30 minutes (Control)

Procedure

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

Primary outcomes

  1. Hemoglobin Drop

    Time frame: within 24 hours after delivery

    The difference between Hemoglobin levels before and after delivery

Secondary outcomes

  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

  7. Hemoglobin Drop

    Time frame: up to 6 weeks postpartum

    The difference between Hemoglobin levels before and after delivery

Study contacts

Contact information is provided by the study sponsor or research team.

Mais Abu Nofal, M.D.

CONTACT

[email protected]

972522245049

Raed Salim, M.D.

CONTACT

[email protected]

0544986960

Sponsors and collaborators

Lead sponsor

Holy Family Hospital, Nazareth, Israel

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2018
Registry last updated
Jul 7, 2026

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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