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When and How to Administer Oxytocin for Active Management of Third Stage of Labour

NCT ID: NCT01954186

Last Updated: 2013-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-12-31

Brief Summary

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To compare the efficacy of the route and timing of oxytocin administration for Active management of third stage of labour (AMTSL).

Detailed Description

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Our objective is to determine the most efficient route and timing of oxytocin administration by measuring the duration of third stage of labour, quantitative blood during the first hour after delivery and comparing haemoglobin and haematocrit changes and the need for additional interventions in patients who had either a spontaneous labour or received labour augmentation with oxytocin.

Conditions

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Postpartum Bleeding

Keywords

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Oxytocin Active Management of Third Stage of Labour

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Participants

Study Groups

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intravenous & intramuscular oxytocin

intravenous or intramuscular 10 iu oxytocin

Group Type EXPERIMENTAL

after delivery of the fetus & when anterior shoulder seen

Intervention Type PROCEDURE

oxytocin 10 iu after the delivery of the fetus or when the anterior shoulder was seen after the fetal head was delivered

after delivery & when anterior shoulder seen

oxytocin 10 iu after the delivery of the fetus or when the anterior shoulder was seen after the fetal head was delivered

Group Type ACTIVE_COMPARATOR

intravenous & intramuscular oxytocin

Intervention Type DRUG

intravenous or intramuscular 10 iu oxytocin

Interventions

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intravenous & intramuscular oxytocin

intravenous or intramuscular 10 iu oxytocin

Intervention Type DRUG

after delivery of the fetus & when anterior shoulder seen

oxytocin 10 iu after the delivery of the fetus or when the anterior shoulder was seen after the fetal head was delivered

Intervention Type PROCEDURE

Other Intervention Names

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Postuitrin

Eligibility Criteria

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Inclusion Criteria

* having a singleton pregnancy above 37th gestational week
* normal live vaginal delivery with cephalic presentation
* being in active labor

Exclusion Criteria

* Fetal demise
* multiple pregnancy
* known coagulation disorder
* presentation anomalies
* placental pathology
* liver disease
* thrombocytopenia
* hypertension or being currently on anticoagulants
* having a cesarean section, operative delivery or deep vaginal tear
* chorioamnionitis
* developing HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count) or DIC (disseminated intravascular coagulation) before delivery
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

UNKNOWN

Sponsor Role lead

Responsible Party

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SEZİN ERTURK AKSAKAL

gynecologist and obstetrician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Berna DILBAZ, Assoc. Prof.

Role: STUDY_DIRECTOR

Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital, Obstetrics and Gynecology, Ankara, Turkey ,

Emire OGUZ ORHAN, MD

Role: STUDY_CHAIR

Sivas State Hospital

Sezin ERTURK AKSAKAL, MD

Role: PRINCIPAL_INVESTIGATOR

Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital, Obstetrics and Gynecology, Ankara, Turkey

Sibel ALTINBAS, Assist. Prof.

Role: STUDY_CHAIR

Hacettepe University Kastamonu Medical Faculty, Obstetrics and Gynecology, Ankara, Turkey,

Salim ERKAYA, Assoc. Prof.

Role: STUDY_CHAIR

Zekai Tahir Burak Maternity and Teaching Hospital, Obstetrics and Gynecology, Ankara, Turkey

Locations

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Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.

Reference Type DERIVED
PMID: 33169839 (View on PubMed)

Oguz Orhan E, Dilbaz B, Aksakal SE, Altinbas S, Erkaya S. Prospective randomized trial of oxytocin administration for active management of the third stage of labor. Int J Gynaecol Obstet. 2014 Nov;127(2):175-9. doi: 10.1016/j.ijgo.2014.05.022. Epub 2014 Jul 17.

Reference Type DERIVED
PMID: 25108586 (View on PubMed)

Other Identifiers

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EtlikWHTH

Identifier Type: -

Identifier Source: org_study_id