NCT03591679

Brief Summary

The patients were recruited from women attending labor ward to undergo cesarean section.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,070

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 11, 2019

Status Verified

March 1, 2019

Enrollment Period

12 months

First QC Date

July 8, 2018

Last Update Submit

March 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • mean Blood loss after placental separation

    by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set

    30 minutes

Study Arms (2)

study group

EXPERIMENTAL

patients at risk of uterine atony undergoing cesarean section underwent bilateral uterine artery ligation and received oxytocin.

Drug: OxytocinProcedure: bilateral uterine artery ligation

control group

ACTIVE COMPARATOR

patients at risk of uterine atony undergoing cesarean section received oxytocin only.

Drug: Oxytocin

Interventions

20 units by slow intravenous drip injection

control groupstudy group

• The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally.

study group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women with one or more of the following conditions undergoing cesarean section for obstetric indication were included:
  • Maternal anemia (not less than 7 gm %).
  • Macrosomic baby \>4kgs.
  • Twin pregnancy and high order pregnancy.
  • Polyhydramnios.
  • Grand multipara.
  • Previous history of atonic postpartum hemorrhage.
  • Prolonged vaginal delivery.
  • Emergency cesarean.
  • Chorioamnionitis.

You may not qualify if:

  • \- Placenta previa.
  • Patients with bleeding tendency (congenital or acquired)
  • Ante-partum hemorrhage.
  • Patients with no risk for uterine atony.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

Related Publications (1)

  • Samy A, Ali MK, Abbas AM, Wahab HA, Wali AA, Hussien AH, Mostafa M, Taymour MA, Ogila AI, Ahmad Y, Essam A, Mahmoud M. Randomized controlled trial of the effect of bilateral uterine artery ligation during cesarean among women at risk of uterine atony. Int J Gynaecol Obstet. 2020 Feb;148(2):219-224. doi: 10.1002/ijgo.13064. Epub 2019 Dec 10.

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 8, 2018

First Posted

July 19, 2018

Study Start

December 1, 2017

Primary Completion

November 30, 2018

Study Completion

January 1, 2019

Last Updated

March 11, 2019

Record last verified: 2019-03

Locations