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

NCT02485444 | Completed Phase 4

• 1 other identifier: 2015-80
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• Blood loss estimated by gravimetric method

  within 10 minutes after delivery of placenta

• Transfusion rate

  Within 7 days of hospitalization

• Change in hemoglobin measured by difference in hemoglobin before and 24-hour after abortion

  24 hours after delivery of placenta

• Placenta delivery time measured by time elapsed until the delivery of the placenta from the delivery of foetus

  5 minute after delivery of placenta

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR

Drug: Oxytocin

Observation

NO INTERVENTION

Interventions

Oxytocin DRUG

20 IU oxytocin in 500 ml normal saline will be infused 100 ml/h i.v. after fetus is delivered

Also known as: Synpitan, Pitocin

Oxytocin

Eligibility Criteria

• Age: 17 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk Üniversitesi Araştırma Hastanesi

Erzurum, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Omer E Yapca, MD

  Ataturk University

  STUDY CHAIR

• Ragıp A AL, MD

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 28, 2015
• First Posted: June 30, 2015
• Study Start: June 8, 2015
• Primary Completion: May 31, 2016
• Study Completion: June 10, 2016
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

TU (1)