Maternal Outcomes Following Manual Lysis of the Placenta.
NCT ID: NCT03626844
Last Updated: 2020-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
100 participants
INTERVENTIONAL
2018-11-20
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Manual Lysis after 15 minutes (Intervention)
Manual Lysis of Placenta 15 minutes after Delivery.
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.
Manual lysis after 30 minutes (Control)
Waiting 30 minutes after delivery and then manual lysis of the placenta.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Singleton Pregnancy.
* Epidural Analgesia during delivery.
* Age between 18 and 45 years.
Exclusion Criteria
* 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.
18 Years
45 Years
FEMALE
Yes
Sponsors
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HaEmek Medical Center, Israel
OTHER
Responsible Party
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Principal Investigators
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Raed Salim, M.D.
Role: STUDY_CHAIR
Haemek Medical Center, Afula, Israel
Locations
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Haemek Medical Center
Afula, , Israel
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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0022-18EMC
Identifier Type: -
Identifier Source: org_study_id
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