Oxytocin Infusion vs. Spontaneous Follow-up for Third-sta... | NCT02485444

Studies
Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage of Labor After Second-trimester Abortion

NCT02485444

Sponsor

Ataturk University

Status

Completed

Last Update Posted

Feb 28, 2023Actual

Enrollment

160Actual

Phase

Phase 4

Conditions

Abortion, Induced
Labor Stage, Third/Drug Effects
Pregnancy Trimester, Second
Oxytocin/Administration & Dosage

Interventions

Oxytocin

Countries

Turkey (Türkiye)

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

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 8, 2015Actual

Primary Completion Date

May 31, 2016Actual

Completion Date

Jun 10, 2016Actual

First Submitted Date

Jun 28, 2015

First Submission Date that Met QC Criteria

Jun 29, 2015

First Posted Date

Jun 30, 2015Estimated

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

Feb 25, 2023

Last Update Posted Date

Feb 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study compares oxytocin infusion to spontaneous follow-up for third-stage of labor at induced mid-trimester abortions. Patients will be randomized to oxytocin infusion or observation with no pharmacologic intervention. Primary outcome of the study is complete abortion rate within two hours of fetal delivery.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxytocin	Active Comparator		Drug: Oxytocin
Observation	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxytocin	Drug	20 IU oxytocin in 500 ml normal saline will be infused 100 ml/h i.v. after fetus is delivered	Oxytocin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete abortion rate	expulsion of placenta completely without an instrumental assistance within two hours after delivery of fetus	within 5 minute after placenta delivered

Secondary Outcomes

Measure	Description	Time Frame
Blood loss estimated by gravimetric method	blood loss will be estimated by gravimetric method	within 10 minutes after delivery of placenta
Transfusion rate	number of packed red cell units transfused

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-Women who had mid-trimester termination of pregnancy between 13-24 gestational weeks

Exclusion Criteria:

If fetus and placenta expelled together
Obstetrical haemorrhage needs intervention
Known prostaglandin allergy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Omer E Yapca, MD	Ataturk University	Study Chair
Ragıp A AL, MD	Ataturk University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Atatürk Üniversitesi Araştırma Hastanesi		Erzurum		25240	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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