Maternal Outcomes Following Manual Lysis of the Placenta.

Third Stage of Delivery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03626844
• Other study ID #: 0022-18EMC
• Status: Suspended
• Phase: N/A
• Start date: November 20, 2018
• Est. completion date: September 2020

Study information

• Verified date: February 2020
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Third Stage of Delivery

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Haemek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View Citation

Setubal A, Clode N, Bruno-Paiva JL, Roncon I, Graça 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. — View 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. — View Citation

Tunçalp O, Souza JP, Gülmezoglu 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin Drop	The difference between Hemoglobin levels before and after delivery	within 24 hours after delivery
Secondary	Rate of Blood Products Given	Number and type of blood products given peripartum	7 days
Secondary	Blood Loss	Calculation of estimated blood loss during delivery by accepted formulas	7 days
Secondary	Febrile morbidity	Rate of developing fever after delivery	within one week of delivery
Secondary	First Nursing	Time until first breastfeeding	7 days
Secondary	Hospital Stay	Length of Hospital stay in days	7 days
Secondary	Maternal Satisfaction	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 days