## Protocol Section
### Identification Module
**NCT ID:** NCT03591679

**Brief Title:** Bilateral Uterine Artery Ligation in Reducing Incidence of Postpartum Hemorrhage in Cesarean Section

**Official Title:** Role of Bilateral Uterine Artery Ligation in Reducing Incidence of Postpartum Hemorrhage in Cesarean Section in Patients At Risk of Uterine Atony A Randomized Controlled Trial

#### Organization Study ID Info
**ID:** BUALCS
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2019-01-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-03-11

**Type:** ACTUAL

**Last Update Submit Date:** 2019-03-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-11-30

**Type:** ACTUAL

#### Start Date
**Date:** 2017-12-01

**Type:** ACTUAL

**Status Verified Date:** 2019-03

#### Study First Post Date
**Date:** 2018-07-19
**Type:** ACTUAL
**Study First Submit Date:** 2018-07-08
**Study First Submit QC Date:** 2018-07-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Assiut University

#### Responsible Party

**Investigator Affiliation:** Assiut University

**Investigator Full Name:** Ahmed Mohamed Abbas

**Investigator Title:** Principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The patients were recruited from women attending labor ward to undergo cesarean section.

### Conditions Module

**Conditions:**

- Post Partum Hemorrhage

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 1070

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Oxytocin

- Procedure: bilateral uterine artery ligation

**Label:** study group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Drug: Oxytocin

**Label:** control group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- control group

- study group

**Description:** 20 units by slow intravenous drip injection

**Name:** Oxytocin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- study group

**Description:** • 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.

**Name:** bilateral uterine artery ligation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** mean Blood loss after placental separation

**Time Frame:** 30 minutes

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

Exclusion Criteria:

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

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Assiut

**Country:** Egypt

**Facility:** Ahmed Abbas

**State:** Cairo

**Zip:** 002

### References Module

#### References

**Citation:** 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.

**PMID:** 31755559

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011644

- Term: Puerperal Disorders

- ID: D000014592

- Term: Uterine Hemorrhage

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: HIGH

- As Found: Hemorrhage

- ID: M9559

- Name: Postpartum Hemorrhage

- Relevance: HIGH

- As Found: Post Partum Hemorrhage

- ID: M17341

- Name: Uterine Inertia

- Relevance: LOW

- As Found: Unknown

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14499

- Name: Puerperal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17340

- Name: Uterine Hemorrhage

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006473

- Term: Postpartum Hemorrhage

- ID: D000006470

- Term: Hemorrhage

### Intervention Browse Module - Ancestors

- ID: D000010120

- Term: Oxytocics

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M13041

- Name: Oxytocin

- Relevance: HIGH

- As Found: Joint

### Intervention Browse Module - Meshes

- ID: D000010121

- Term: Oxytocin

### Misc Info Module

- Version Holder: 2024-05-24
