Postpartum Uterotonic Administration

NCT ID: NCT02495272

Last Updated: 2015-07-13

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-01-31

Brief Summary

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The investigators are planning to determine the effect of the timing of oxytocin administration on the amount of blood loss, necessity for additional medical or surgical interventions.

Detailed Description

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The investigators are studying the effects of the timing of intramuscular oxytocin administration in the third stage of labour. The investigators are measuring the postpartum blood loss: quantitatively in the postpartum 1st hour and indirectly by the decrease in the hemoglobin-haematocrit levels in the postpartum 24th hour. The investigators are monitoring the length of the third stage of labour, and the need for extra uterotonics and/or surgical interventions.

Conditions

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Postpartum Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control Group

Oxytocin 10IU im was administered after placental delivery

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Oxytocin 10IU Administered intramuscularly.

Study Group

Oxytocin 10IU im was administered after the anterior shoulder could be seen.

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Oxytocin 10IU Administered intramuscularly.

Interventions

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Oxytocin

Oxytocin 10IU Administered intramuscularly.

Intervention Type DRUG

Other Intervention Names

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PostuitrinFort Amp I.E.Ulagay

Eligibility Criteria

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Inclusion Criteria

* Cephalic presentation
* Singleton pregnancy
* Gestational age \>35 weeks,
* In active labour.
* Expected fetal birth weight 2500-4500 grams.

Exclusion Criteria

* Acute Fetal Distress
* Conversion to abdominal delivery
* Persistent high blood pressure (\>140/90mmHg)
* Placenta Previa
* Ablatio placenta
* Previous C-Section
* Uterine scar
* Postpartum hemorrhage in previous pregnancies.
* Hydramnios
* Maternal infection
* Forceps/Vacuum Assisted deliveries
* Abnormal placentation ( Placenta accreta, increta or percreta)
* Coagulation Defects
* Hemoglobin \< 8g/dl
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role collaborator

Bagcilar Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Eser Sefik Ozyurek

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Burak Ozkose, MD

Role: STUDY_CHAIR

Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul

Dogukan Yildirim, MD

Role: PRINCIPAL_INVESTIGATOR

Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul

Eser S Ozyurek, MD

Role: STUDY_CHAIR

Bagcilar Training and Research Hospital

Batuhan Ustun, MD

Role: STUDY_CHAIR

Kanuni Sultan Suleyman Teaching and Research Hospital, Istanbul

Locations

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Kanuni Sultan Suleyman Teaching and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Dogukan Yildirim, MD

Role: CONTACT

+905063284383

Eser S Ozyurek, MD

Role: CONTACT

+905309322345

Facility Contacts

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Dogukan Yıldırım, MD

Role: primary

+905063284383

References

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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 BACKGROUND
PMID: 25108586 (View on PubMed)

Other Identifiers

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Kanuni-Bagcilar

Identifier Type: -

Identifier Source: org_study_id

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