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Not yet recruiting NCT03626844

Maternal Outcomes Following Manual Lysis of the Placenta.

No phase Interventional Third Stage of Delivery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Manual Lysis of Placenta after 15 minutes (Intervention), Manual Lysis of Placenta after 30 minutes (Control).
Who it may be relevant to
Registry conditions: Third Stage of Delivery. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Hemoglobin Drop [Time frame: within 24 hours after delivery]
Secondary outcome measures (7)
  • Rate of Blood Products Given [Time frame: 7 days]
  • Blood Loss [Time frame: 7 days]
  • Febrile morbidity [Time frame: within one week of delivery]
  • First Nursing [Time frame: 7 days]
  • Hospital Stay [Time frame: 7 days]
  • Maternal Satisfaction [Time frame: 7 days]
  • Hemoglobin Drop [Time frame: up to 6 weeks postpartum]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Israel · 1 center
  • Haemek Medical Center — Afula

Publications

  • Deneux-Tharaux C, Macfarlane A, Winter C, Zhang WH, Alexander S, Bouvier-Colle MH; EUPHRATES Group. Policies for manual removal of placenta at vaginal delivery: variations in timing within Europe. BJOG. 2009 Jan;116(1):119-24. doi: 10.1111/j.1471-0528.2008.01996.x. PMID 19087083
  • Weeks AD. The retained placenta. Best Pract Res Clin Obstet Gynaecol. 2008 Dec;22(6):1103-17. doi: 10.1016/j.bpobgyn.2008.07.005. Epub 2008 Sep 14. PMID 18793876
  • Shinar S, Schwartz A, Maslovitz S, Many A. How Long Is Safe? Setting the Cutoff for Uncomplicated Third Stage Length: A Retrospective Case-Control Study. Birth. 2016 Mar;43(1):36-41. doi: 10.1111/birt.12200. Epub 2015 Nov 10. PMID 26555024
  • Tuncalp O, Souza JP, Gulmezoglu M; World Health Organization. New WHO recommendations on prevention and treatment of postpartum hemorrhage. Int J Gynaecol Obstet. 2013 Dec;123(3):254-6. doi: 10.1016/j.ijgo.2013.06.024. Epub 2013 Aug 30. PMID 24054054
  • Obajimi GO, Roberts AO, Aimakhu CO, Bello FA, Olayemi O. An appraisal of retained placentae in ibadan: a five year review. Ann Ib Postgrad Med. 2009 Jun;7(1):21-5. doi: 10.4314/aipm.v7i1.64058. PMID 25161458
  • Morales M, Ceysens G, Jastrow N, Viardot C, Faron G, Vial Y, Kirkpatrick C, Irion O, Boulvain M. Spontaneous delivery or manual removal of the placenta during caesarean section: a randomised controlled trial. BJOG. 2004 Sep;111(9):908-12. doi: 10.1111/j.1471-0528.2004.00228.x. PMID 15327603
  • Setubal A, Clode N, Bruno-Paiva JL, Roncon I, Graca LM. Vesicouterine fistula after manual removal of placenta in a woman with previous cesarean section. Eur J Obstet Gynecol Reprod Biol. 1999 May;84(1):75-6. doi: 10.1016/s0301-2115(98)00305-4. PMID 10413231
  • Akinola OI, Fabamwo AO, Oludara B, Akinola RA, Oshodi YA, Adebayo SK. Ruptured uterus and bowel injury from manual removal of placenta: a case report. Niger Postgrad Med J. 2012 Sep;19(3):181-3. PMID 23064176

Identifiers

NCT: NCT03626844 · HFHOSP-322-26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗