Intravenous and Intramuscular Administration of Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via IV infusion results in a lower mean blood loss compared to IM injection.
| Condition | Intervention |
|---|---|
|
Postpartum Hemorrhage |
Drug: Oxytocin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Intravenous and Intramuscular Administration of Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage |
- Mean blood loss (ml) [ Time Frame: minimum of 1 hour after delivery of baby ] [ Designated as safety issue: No ]
- Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml [ Designated as safety issue: No ]
- Change in hemoglobin from pre-delivery to postpartum [ Time Frame: 12-24 hours after delivery ] [ Designated as safety issue: No ]Post-delivery hemoglobin using a Hemocue® Hemoglobin machine + cuvette will be taken at least 24 after delivery and before the woman leaves the facility. If the woman has received IV fluids, hemoglobin will be measured at least 12 hours after removal of the IV prior to discharge.
- Time to placental delivery [ Designated as safety issue: No ]
- Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy [ Designated as safety issue: No ]
- Side effects 1 hour postpartum [ Time Frame: 1 hour postpartum ] [ Designated as safety issue: No ]
- Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward [ Designated as safety issue: No ]
| Estimated Enrollment: | 644 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: IV infusion
Oxytocin 10 IU will be administered IV infusion according to randomization assignment as soon as possible after delivery of the baby.
|
Drug: Oxytocin
10 IU oxytocin in 500 ml infusion
|
|
Active Comparator: IM Injection
Oxytocin 10 IU will be administered IM according to randomization assignment as soon as possible after delivery of the baby.
|
Drug: Oxytocin
10 IU oxytocin IM injection
|
Detailed Description:
The study will compare the effect of IV infusion and IM oxytocin administration on the proportion of women who experience blood loss greater than or equal t 350 ml, the proportion of women who experience blood loss greater than or equal to 500 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery. It will also assess whether a bleeding history questionnaire can identify women at risk for excessive bleeding and help to define the distribution of bleeding scores among women with and without excessive bleeding.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- All women who present in active labor for a live birth at the study hospital will be considered for participation in the study
Exclusion Criteria: Women who are:
- Planned or transferred for delivery via Cesarean section
- Not delivering a live birth
- Unable to provide informed consent due to mental impairment, distress during labor or other reason
- Unwilling and/or unable to respond to questionnaires about background characteristics and/or bleeding history.
Contacts and Locations| Contact: Ilana Dzuba, MHS | 212-448-1230 | idzuba@gynuity.org |
| Ecuador | |
| Hospital Gineco-Obstétrico Isidro Ayora | Not yet recruiting |
| Quito, Ecuador | |
| Principal Investigator: Rolando Montesinos, MD | |
| Principal Investigator: Wilfrido Leon, MD | |
| Turkey | |
| SB Etlik Zübeyde Hanım Kadın Hastalıkları Eğitim ve Araştırma Hastanesi | Not yet recruiting |
| Ankara, Turkey | |
| Principal Investigator: Berna Dilbaz, MD | |
| Principal Investigator: Orhan Gelisen, MD | |
| Principal Investigator: Salim Erkaya, MD | |
| Vietnam | |
| Huong Vuong Hospital | Recruiting |
| Ho Chi Minh City, Vietnam | |
| Principal Investigator: Nguyen van Truong, MD | |
| Principal Investigator: Nguyen Thi Nhu Ngoc, MD | |
| Principal Investigator: | Beverly Winikoff, MD, MPH | Gynuity Health Projects |
| Principal Investigator: | Ilana Dzuba, MHS | Gynuity Health Projects |
| Principal Investigator: | Jill Durocher | Gynuity Health Projects |
| Principal Investigator: | Jennifer Blum, MPH | Gynuity Health Projects |
More Information
No publications provided
| Responsible Party: | Gynuity Health Projects |
| ClinicalTrials.gov Identifier: | NCT01608958 History of Changes |
| Other Study ID Numbers: | 3000 |
| Study First Received: | May 29, 2012 |
| Last Updated: | June 28, 2012 |
| Health Authority: | Vietnam: Institutional Review Board |
Keywords provided by Gynuity Health Projects:
|
Postpartum hemorrhage Oxytocin Third stage of labor Hemoglobin |
Prevention Intravenous Intramuscular |
Additional relevant MeSH terms:
|
Hemorrhage Postpartum Hemorrhage Uterine Hemorrhage Pathologic Processes Obstetric Labor Complications Pregnancy Complications Puerperal Disorders |
Oxytocin Oxytocics Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013