Clinical trial NCT03626844: Maternal Outcomes Following Manual Lysis of the Placenta.
Official title: Maternal Outcomes Following Manual Lysis of the Placenta After Fifteen Compared to Thirty Minutes. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Third Stage of Delivery
Keywords: Manual Lysis, Postpartum Hemorrhage, Third Stage of Delivery.
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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.

Primary outcomes:
measure: Hemoglobin Drop
timeFrame: within 24 hours after delivery
Secondary outcomes:
measure: Rate of Blood Products Given
timeFrame: 7 days
measure: Blood Loss
timeFrame: 7 days
measure: Febrile morbidity
timeFrame: within one week of delivery
measure: First Nursing
timeFrame: 7 days
measure: Hospital Stay
timeFrame: 7 days
measure: Maternal Satisfaction
timeFrame: 7 days
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
affiliation: Haemek Medical Center, Afula, Israel
name: Raed Salim, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.