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NCT02485444 Clinical Trial

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

Abortion, Induced Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02485444
Other study ID # 2015-80
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 8, 2015
Est. completion date June 10, 2016

Study information
Verified date February 2023
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date June 10, 2016
Est. primary completion date May 31, 2016
Accepts healthy volunteers No
Gender Female
Age group 17 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Turkey Atatürk Üniversitesi Arastirma Hastanesi Erzurum

Sponsors (1)
Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Blood loss estimated by gravimetric method blood loss will be estimated by gravimetric method within 10 minutes after delivery of placenta
Secondary Transfusion rate number of packed red cell units transfused Within 7 days of hospitalization
Secondary Change in hemoglobin measured by difference in hemoglobin before and 24-hour after abortion Difference in hemoglobin before and 24-hour after abortion 24 hours after delivery of placenta
Secondary Placenta delivery time measured by time elapsed until the delivery of the placenta from the delivery of foetus The time elapsed until the delivery of the placenta from the delivery of foetus 5 minute after delivery of placenta
See also
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Completed NCT00177333 - Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens Phase 4
Completed NCT00370487 - Comparison of the Safety of First Trimester Abortions Performed by Physicians and Non-Physicians in South Africa and Viet Nam. N/A
Completed NCT00188071 - Postoperative Pain After Medical Abortion Under Local Anesthesia : Comparison of Several Analgesic Regimen N/A
Completed NCT02277249 - Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion N/A
Completed NCT00386867 - A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP N/A
Completed NCT00677755 - Medical Abortion for Emergency Contraception Failure N/A
Completed NCT02279914 - Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial N/A
Completed NCT01597726 - Cervical Priming Before Dilation & Evacuation N/A
Completed NCT01615731 - Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks N/A
Completed NCT02318212 - Dilapan-S / Dilasoft E-Registry in Induced Abortion N/A
Terminated NCT00855842 - Pilot Study of the Addition of Osmotic Dilators to Preparation Prior to Labor Induction Abortion N/A
Completed NCT00330993 - Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation Phase 2
Completed NCT00382538 - Mifepristone and Mid-Trimester Termination of Pregnancy N/A
Completed NCT03080493 - Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial Phase 4
Completed NCT00969982 - Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP)) N/A
Recruiting NCT02480543 - Different Routes of Misoprostol Prior to First Trimester Surgical Abortion Phase 4
Completed NCT00870272 - Study of 400mcg Sublingual Versus 400mcg Buccal Misoprostol Following 200mg Mifepristone for Medical Abortion up to 63 Days Last Menstrual Period (LMP) N/A
Completed NCT02048098 - Misoprostol for Second Trimester Termination of Pregnancy Phase 3
Completed NCT01751087 - Cervical Preparation Before Dilation and Evacuation N/A