Oxytocin for Reducing Bleeding
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Colorado, Denver
Must not be taking: Anticoagulants, Misoprostol
Disqualifiers: Coagulopathy, Sepsis, Placenta accreta, others
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to assess the effectiveness of prophylactic oxytocin on hemorrhage rates for second trimester dilation and evacuation (D\&E) in the clinic setting.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used anticoagulants (blood thinners) in the five days before the trial.
What data supports the effectiveness of the drug oxytocin for reducing bleeding?
Research shows that oxytocin is a commonly used drug to prevent postpartum hemorrhage (heavy bleeding after childbirth) and is considered the first-line treatment in the United States for this purpose. It is often used in combination with other drugs to enhance its effectiveness in preventing excessive bleeding.
12345How is the drug oxytocin unique in reducing bleeding?
Oxytocin is unique because it is a commonly used uterotonic agent (a drug that induces contraction of the uterus) to prevent postpartum hemorrhage, but there is no established standard dose, and its administration varies widely. It is particularly recommended in low-resource settings despite challenges, and it is considered effective with minimal side effects when used under proper supervision.
12678Eligibility Criteria
This trial is for individuals undergoing a clinic-based dilation and evacuation (D&E) procedure at or beyond 18 weeks of pregnancy. Participants must be able to communicate in either English or Spanish.Inclusion Criteria
I speak English or Spanish.
I am over 18 weeks pregnant and can visit a clinic for check-ups.
Exclusion Criteria
I refuse to receive treatments through an IV.
Multiple gestation
I have used blood thinners in the last 5 days.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive either 40 units IV oxytocin in 1000 mL of normal saline or 1000 mL of normal saline alone at the time of tenaculum placement for D&E
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of hemorrhage and patient satisfaction
1-2 weeks
Participant Groups
The study is testing whether giving oxytocin mixed with normal saline before the D&E can reduce bleeding compared to just normal saline. It's designed to see if this approach is effective in preventing hemorrhage during the second trimester D&E procedures.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OxytocinExperimental Treatment1 Intervention
Participants receive 40 units IV oxytocin in 1000 mL of normal saline at the time of tenaculum placement for D\&E.
Group II: PlaceboPlacebo Group1 Intervention
Participants receive 1000 mL of normal saline alone at the time of tenaculum placement for D\&E.
Oxytocin is already approved in United States, European Union, Canada, Australia for the following indications:
πΊπΈ Approved in United States as Pitocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
πͺπΊ Approved in European Union as Syntocinon for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
π¨π¦ Approved in Canada as Oxytocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
π¦πΊ Approved in Australia as Oxytocin for:
- Induction of labor
- Augmentation of labor
- Control of postpartum bleeding
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Comprehensive Women's Health CenterDenver, CO
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Who Is Running the Clinical Trial?
University of Colorado, DenverLead Sponsor
References
Carbetocin versus oxytocin for prevention of postpartum hemorrhage in hypertensive women undergoing elective cesarean section. [2021]Assess the efficacy and safety of carbetocin, versus oxytocin in the prevention of postpartum hemorrhage in hypertensive women.
Variations in oxytocin regimes in Scottish labour wards in 1998. [2004]Oxytocin (Syntocinon, Sandoz Pharmaceuticals) is a commonly used drug in the modern management of labour. A recently published British survey found that 38% of low risk primigravid labours were augmented, most commonly by intravenous syntocinon. Unfortunately the misuse of syntocinon can lead to potentially serious problems for the fetus and mother. Despite the frequency of usage there appears to be no consensus as to the optimal dose and mode of administration. This paper explores the extent of this variation among Scottish obstetric units, the reasons for any variation in its use and makes some suggestions as to the way forward based on the current literature.
Preventing postpartum hemorrhage with combined therapy rather than oxytocin alone. [2023]Postpartum hemorrhage is the leading cause of maternal morbidity and mortality worldwide, with uterine atony estimated to account for 70% to 80% of cases, thereby remaining the single most common cause. Pharmacotherapy remains the first-line preventative therapy for postpartum hemorrhage. These therapies may be single (oxytocin, carbetocin, methylergonovine, ergometrine, misoprostol, prostaglandin analogs, or tranexamic acid) or combination therapies, acting in an additive, infra-additive, or synergistic fashion to prevent postpartum hemorrhage. Evidence is strong for the use of oxytocin, the first-line uterotonic agent in the United States for prevention of postpartum hemorrhage. Although carbetocin, a long-acting analog of oxytocin, is not yet available for use in the United States, it is likely the most effective single pharmacologic therapy for prevention of postpartum hemorrhage and need for additional uterotonics. Use of second-line uterotonics such as methylergonovine, misoprostol, and carboprost in combination with oxytocin has an additive or synergistic effect and a greater risk reduction for postpartum hemorrhage prevention compared with oxytocin alone. Therefore, combined therapy rather than oxytocin alone should be advised for preventing postpartum hemorrhage. Tranexamic acid has been found to be both effective and safe for decreasing maternal mortality in women with postpartum hemorrhage, and prophylactic use of tranexamic acid may decrease the need for packed red blood cell transfusions and/or uterotonics. The WOMAN-2 Trial, designed to assess if tranexamic acid prevents postpartum hemorrhage in women with moderate to severe anemia undergoing vaginal delivery, is currently recruiting participants. The additive, infra-additive, or synergistic action of oxytocin in combination with other second-line therapies deserves further study.
The compatibility of oxytocin and tranexamic acid injection products when mixed for co-administration by infusion for the treatment of postpartum haemorrhage: An in vitro investigation. [2023]To investigate the compatibility of oxytocin and tranexamic acid injection products when mixed for the purpose of co-administration by intravenous infusion.
Evaluation of in vivo effects of Oxytocin on coagulation of parturient during cesarean delivery by thromboelastography. [2021]Oxytocin routinely used as an uterotonic drug in cesarean delivery. Clothing problems, adverse effects on fibrinogen and bleeding were presented as side effects of oxytocin. In in vivo investigation, modest hypercoagulable state was suggested as a side effect for infusion of oxytocin in parturients. In this study, effects of two different infusion rates of oxytocin on coagulation of parturient were evaluated during cesarean delivery.
Synthetic oxytocin. [2018]A synthetic oxytocin, Syntocinon(R), was used in 3,342 obstetrical patients for a wide variety of indications. It was concluded that the preparation is as effective as natural oxytocin.(1) There were no side effects observed, particularly vasospasm or anaphylactic reaction. Its use in clinical obstetrics can be recommended provided there is a proper indication for its use and the need for close supervision and individual adjustment of dosage is recognized.
Dose and duration of oxytocin to prevent postpartum hemorrhage: a review. [2022]Oxytocin, the most commonly used uterotonic agent in the United States to prevent postpartum hemorrhage, has no established standard dose. The aim of this review is to present data on oxytocin dosing for the prevention of postpartum hemorrhage.
[The Role of Oxytocin in the Prevention of Postpartum Hemorrhage in Low-Resource Settings]. [2022]Postpartum hemorrhage remains one of the leading causes of maternal death globally. Oxytocin is the uterotonic agent of choice for the prophylaxis of this complication. However, its use in low-resource settings is associated with clinical, political, economic and cultural constraints. The goal of this article is to describe the use of oxytocin for postpartum hemorrhage prophylaxis in low-resource settings.