Clinical trial NCT01954186: When and How to Administer Oxytocin for Active Management of Third Stage of Labour
Official title: When and How to Administer Oxytocin for Active Management of Third Stage of Labour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Bleeding
Keywords: Oxytocin
Active Management of Third Stage of Labour
Lead sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Sponsor class: OTHER
First posted: 2013-10-01
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: postpartum bleeding in the third stage of labour
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital
Study officials:
affiliation: Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital, Obstetrics and Gynecology, Ankara, Turkey ,
name: Berna DILBAZ, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Sivas State Hospital
name: Emire OGUZ ORHAN, MD
role: STUDY_CHAIR
affiliation: Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital, Obstetrics and Gynecology, Ankara, Turkey
name: Sezin ERTURK AKSAKAL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University Kastamonu Medical Faculty, Obstetrics and Gynecology, Ankara, Turkey,
name: Sibel ALTINBAS, Assist. Prof.
role: STUDY_CHAIR
affiliation: Zekai Tahir Burak Maternity and Teaching Hospital, Obstetrics and Gynecology, Ankara, Turkey
name: Salim ERKAYA, Assoc. Prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.