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Completed

NCT Number: NCT02485444

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

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.

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Key information

Conditions

Abortion, Induced Labor Stage, Third/Drug Effects Neoplasm Metastasis Neoplasms Neoplastic Processes Oxytocin/Administration & Dosage Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Trimester, Second

Age range

17 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Atatürk Üniversitesi Araştırma Hastanesi

Erzurum, 25240, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

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

Other names: Synpitan, Pitocin

Primary outcomes

  1. Complete abortion rate

    Time frame: within 5 minute after placenta delivered

    expulsion of placenta completely without an instrumental assistance within two hours after delivery of fetus

Secondary outcomes

  1. Blood loss estimated by gravimetric method

    Time frame: within 10 minutes after delivery of placenta

    blood loss will be estimated by gravimetric method

  2. Transfusion rate

    Time frame: Within 7 days of hospitalization

    number of packed red cell units transfused

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

    Time frame: 24 hours after delivery of placenta

    Difference in hemoglobin before and 24-hour after abortion

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

    Time frame: 5 minute after delivery of placenta

    The time elapsed until the delivery of the placenta from the delivery of foetus

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage Management After Second-trimester Abortion: A Randomized Clinical Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 30, 2015
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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