Standard Oxytocin Versus High Dose Oxytocin to Control Po... | NCT06560099

Studies
Standard Oxytocin Versus High Dose Oxytocin to Control Postpartum Hemorrhage in High Risk Pregnancy During Elective Cesarean Section

NCT06560099

Sponsor

Ain Shams University

Status

Not yet recruiting

Last Update Posted

Aug 19, 2024Actual

Enrollment

39Estimated

Phase

Not Applicable

Conditions

Post Partum Hemorrhage

Interventions

Oxytocin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 25, 2024Estimated

Primary Completion Date

Apr 25, 2025Estimated

Completion Date

Apr 25, 2025Estimated

First Submitted Date

Aug 15, 2024

First Submission Date that Met QC Criteria

Aug 15, 2024

First Posted Date

Aug 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2024

Last Update Posted Date

Aug 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Controlling hemorrhage during and after a cesarean section reduces significantly maternal mortality and morbidity and the present study is important for detection of the effectiveness of routinely increasing the oxytocin dose instead of using the standard dose only in preventing postpartum hemorrhage and additional use of uterotonics in the first 24 hours after cesarean section for high risk pregnancy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A (standard oxytocin dose)	Active Comparator		Drug: Oxytocin
Group B (high dose oxytocin)	Active Comparator		Drug: Oxytocin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxytocin	Drug	will receive 10 IU oxytocin intravenous bolus over one min and infusion of 10 IU oxytocin in 500 ml of 0.9 saline over four hours.	Group A (standard oxytocin dose)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
blood loss	measure blood in suction, towels and pads	at the end of the operation

Secondary Outcomes

Measure	Description	Time Frame
haemoglobin	by laboratory asessment	immediate preoperative
haemoglobin	by laboratory asessment	6 hours postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Medical disorders ie: Hypertensive diseases with pregnancy - Diabetes Mellitus - Collagen diseases - Coagulopathies - Cardiac diseases - Anemia
History of postpartum hemorrhage
Placental disorders ie: placenta previa
Infertility and ICSI
High Parity
History of Endometriosis
Fetal disorders (IUGR, IUFD, Preterm, Congenital anomalies, oligohydramnios or polyhydramnios, macrosomia)
Preterm labor on uterine relaxants
Twins pregnancy
Patients on antiplatelets and anticoagulants
Uneventful antenatal care

Exclusion Criteria:

- Oxytocin Allergy
Normal uncomplicated pregnancy
Emergency cesarean section
Exhausted uterus due to trial of normal labor
Couvelaire uterus

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006473	Postpartum Hemorrhage

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010121	Oxytocin

Ancestor Terms

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided