CLINICAL TRIALS PROFILE FOR HEMABATE

All Clinical Trials for HEMABATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00989027 ↗	Impact of Uterotonic Agents on Isolated Human Myometrium	Completed	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	N/A	2007-06-01	The purpose of this study is to compare the ability of a sample of uterine muscle tissue to contract in the presence of various drugs. The drugs studied are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. Amongst the uterotonic drugs (used to contract the uterus), namely oxytocin, ergonovine and carboprost, the most effective one to use is not known. The investigators will be testing uterine muscle samples in the presence of these drugs at various concentrations, to see what their contractility measures over time, as compared with a control sample, in which no drugs will be applied.
NCT01869556 ↗	Comparison of IV Ergonovine With IM Carboprost, With Oxytocin IV, During Cesarean Section for Failure to Progress	Completed	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	N/A	2013-06-04	Patients having Cesarean section after they have been in labor for many hours bleed much more, in average twice as much, as compared with patients having an elective Cesarean section. The investigators believe a simple change in practice might contribute to reduce this bleeding. This study will involve the use of oxytocin (also known as syntocinon), ergonovine (also known as ergot) and carboprost (also known as hemabate). Oxytocin is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta, so as to reduce the amount of blood loss. Ergonovine is also given through the intravenous line, while carboprost is given as an injection in the muscle. Although they are not routinely given in every case, these are very frequently given as rescue medications to patients who fail to respond appropriately to oxytocin. This study is designed to determine if ergonovine or carboprost given in association with oxytocin, in a preventive way, after delivery of the baby and placenta, can reduce the amount of blood loss during Cesarean sections following a trial of labour.
NCT02220361 ↗	Dexmedetomidine on Prevention of Side Effects of Hemabate	Unknown status	Jin Ni	Phase 4	2014-09-01	Hemabate is often used for gynecological patients. Hemabate is associated with many side effects, including a burning sensation in the stomach, nausea, vomiting, diarrhea etc. It is reported that dexmedetomidine reduce gastrointestinal reaction during perioperative period. We design this clinical trial to find if dexmedetomidine can prevent the side effects of hemabate in Cesarean Section patients.
NCT02861482 ↗	Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage	Completed	Baoan District People's Hospital of Shenzhen	N/A	2015-01-01	Postpartum hemorrhage (PPH) is the top reason for maternal deaths in China. The four major causes of PPH include uterine atony, genital tract laceration, placenta factors and systemic medical disorders (including inherited and acquired coagulopathy). Management of PPH contains the application of uterotonic agents, using hemostasis agents, transfusion of blood component products, conservative procedures (intrauterine packing or balloon tamponade, compression sutures, vascular ligation and uterine artery embolization using sponges), and even hysterectomy. The Bakri Balloon has attained its efficacy and popularity ever since it was invented by Doctor YN. Bakri. Although it is recommended by many countries as a routine procedure for PPH management, the Bakri Balloon is not yet a first choice in China due to lack in clinical data of preventive usage. The aim of this study is to prove the efficacy and safety of the Bakri Balloon in early management of PPH.
NCT02861482 ↗	Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage	Completed	Dongguan Maternity & Child Health Hospital	N/A	2015-01-01	Postpartum hemorrhage (PPH) is the top reason for maternal deaths in China. The four major causes of PPH include uterine atony, genital tract laceration, placenta factors and systemic medical disorders (including inherited and acquired coagulopathy). Management of PPH contains the application of uterotonic agents, using hemostasis agents, transfusion of blood component products, conservative procedures (intrauterine packing or balloon tamponade, compression sutures, vascular ligation and uterine artery embolization using sponges), and even hysterectomy. The Bakri Balloon has attained its efficacy and popularity ever since it was invented by Doctor YN. Bakri. Although it is recommended by many countries as a routine procedure for PPH management, the Bakri Balloon is not yet a first choice in China due to lack in clinical data of preventive usage. The aim of this study is to prove the efficacy and safety of the Bakri Balloon in early management of PPH.
NCT02861482 ↗	Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage	Completed	First Affiliated Hospital, Sun Yat-Sen University	N/A	2015-01-01	Postpartum hemorrhage (PPH) is the top reason for maternal deaths in China. The four major causes of PPH include uterine atony, genital tract laceration, placenta factors and systemic medical disorders (including inherited and acquired coagulopathy). Management of PPH contains the application of uterotonic agents, using hemostasis agents, transfusion of blood component products, conservative procedures (intrauterine packing or balloon tamponade, compression sutures, vascular ligation and uterine artery embolization using sponges), and even hysterectomy. The Bakri Balloon has attained its efficacy and popularity ever since it was invented by Doctor YN. Bakri. Although it is recommended by many countries as a routine procedure for PPH management, the Bakri Balloon is not yet a first choice in China due to lack in clinical data of preventive usage. The aim of this study is to prove the efficacy and safety of the Bakri Balloon in early management of PPH.
NCT02861482 ↗	Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage	Completed	Guangzhou Women and Children's Medical Center	N/A	2015-01-01	Postpartum hemorrhage (PPH) is the top reason for maternal deaths in China. The four major causes of PPH include uterine atony, genital tract laceration, placenta factors and systemic medical disorders (including inherited and acquired coagulopathy). Management of PPH contains the application of uterotonic agents, using hemostasis agents, transfusion of blood component products, conservative procedures (intrauterine packing or balloon tamponade, compression sutures, vascular ligation and uterine artery embolization using sponges), and even hysterectomy. The Bakri Balloon has attained its efficacy and popularity ever since it was invented by Doctor YN. Bakri. Although it is recommended by many countries as a routine procedure for PPH management, the Bakri Balloon is not yet a first choice in China due to lack in clinical data of preventive usage. The aim of this study is to prove the efficacy and safety of the Bakri Balloon in early management of PPH.

Clinical Trial Conditions for HEMABATE

Condition Name

Condition Name for HEMABATE
Intervention	Trials
Postpartum Hemorrhage	3
Fibroid Uterus	1
Gynecologic Disease	1
Gynecological Patient	1

Condition MeSH

Condition MeSH for HEMABATE
Intervention	Trials
Postpartum Hemorrhage	3
Hemorrhage	3
Myofibroma	1
Leiomyoma	1

Clinical Trial Locations for HEMABATE

Trials by Country

Trials by Country for HEMABATE
Location	Trials
China	2
Canada	2
United States	1

Trials by US State

Trials by US State for HEMABATE
Location	Trials
Illinois	1

Clinical Trial Progress for HEMABATE

Clinical Trial Phase

Clinical Trial Phase for HEMABATE
Clinical Trial Phase	Trials
Phase 4	2
N/A	3
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for HEMABATE
Clinical Trial Phase	Trials
Completed	4
Recruiting	1
Unknown status	1

Clinical Trial Sponsors for HEMABATE

Sponsor Name

Sponsor Name for HEMABATE
Sponsor	Trials
Samuel Lunenfeld Research Institute, Mount Sinai Hospital	2
Sixth Affiliated Hospital, Sun Yat-sen University	1
Zhongshan Dongsheng hospital	1

Sponsor Type

Sponsor Type for HEMABATE
Sponsor	Trials
Other	28

Clinical Trials Update, Market Analysis, and Projection for Hemabate (Carboprost Tromethamine)

Last updated: October 28, 2025

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Introduction

Hemabate (carboprost tromethamine) is a synthetic prostaglandin F2α analog primarily utilized for obstetric indications, including the induction of second-trimester abortion, postpartum hemorrhage, and pregnancy termination. Since its approval, Hemabate has gained prominence in maternal health management, but ongoing clinical trials and evolving market dynamics influence its strategic positioning. This report provides a comprehensive update on Hemabate’s clinical trials, market landscape, and future growth projection to inform stakeholders.

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Clinical Trials Update

Current Clinical Trials and Research Directions

Historically, Hemabate's approval was based on its efficacy in controlling postpartum hemorrhage and pregnancy termination. However, recent research efforts aim to expand its indications and optimize safety profiles.

• Pregnancy-Induction and Abortifacient Efficiency: Multiple ongoing Phase II and III trials aim to compare Hemabate’s efficacy against other prostaglandins such as misoprostol and dinoprostone. Studies focus on dose optimization, timing, and adverse effects mitigation ([1]).

• Safety Profile in Specific Populations: Trials are examining Hemabate's safety in women with hypertensive disorders, pre-existing cardiac conditions, and in regions with limited healthcare infrastructure ([2]).

• Combination Therapies: Several investigational studies explore combinations of Hemabate with oxytocin and misoprostol to enhance uterotonic effects and reduce side effects ([3]).

Regulatory and Post-Market Surveillance

Post-marketing, pharmacovigilance studies continue to monitor adverse events, particularly bronchospasm and gastrointestinal reactions, which are associated with prostaglandin use ([4]). These real-world data inform dose adjustments and contraindication expansions.

Emerging Trials and Innovations

While Hemabate remains largely under a stable regulatory framework, innovative delivery methods such as controlled-release formulations and alternative routes (e.g., intravaginal) are under preclinical evaluation, targeting improved patient compliance and reduced systemic side effects ([5]).

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Market Analysis

Market Overview and Size

The global obstetric drugs market, including postpartum hemorrhage management and abortion drugs, was valued at approximately USD 1.8 billion in 2022, with a compound annual growth rate (CAGR) of 6.2% projected through 2030 ([6]). Hemabate holds a significant share within this segment due to its proven efficacy, especially in low-resource settings where alternative therapies are limited.

Key Market Drivers

• Rising Maternal Health Focus: Governments and international organizations prioritize maternal health, spurring demand for uterotonics like Hemabate to mitigate postpartum hemorrhage—one of the leading causes of maternal mortality ([7]).

• Regulatory Approvals in Emerging Markets: Expanded registrations in regions such as Southeast Asia, Africa, and Latin America increase access and usage.

• Increasing Incidence of Postpartum Hemorrhage: Growing birth rates and high hemorrhage-related mortality elevate demand.

Competitive Landscape

Hemabate competes with other prostaglandins, misoprostol, and oxytocin. While misoprostol’s oral route and lower cost give it an advantage, Hemabate is preferred when rapid and precise uterine contraction is necessary, especially intraoperatively ([8]).

Major pharmaceutical players such as Pfizer, Schering-Plough (now Merck), and Teva hold dominant positions in uterotonic drugs. However, Hemabate's niche positioning provides a resilient market segment amid price-sensitive environments.

Challenges and Opportunities

• Pricing and Accessibility: In low-resource settings, high costs limit Hemabate adoption; generic formulations could mitigate this barrier.

• Side Effect Profile: Gastrointestinal and bronchospasm adverse events hamper its widespread use in sensitive populations; ongoing trials aim to improve safety.

• Regulatory Constraints: Some countries restrict Hemabate use due to adverse event risks, slowing market penetration.

• Novel Delivery Systems: Developing less invasive administration routes could widen usage, especially in outpatient settings ([9]).

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Market Projection and Future Growth

Short-term (Next 3 Years)

The market growth for Hemabate is expected to be steady, driven by increased demand in emerging markets and expanded clinical evidence supporting its safety and efficacy. The adoption of combination therapy protocols and improved safety data could catalyze broader use.

Medium to Long-term (3-10 Years)

Projection models foresee a CAGR of approximately 5.5% through 2030, aligning with the broader obstetric pharmacotherapy market. The following factors underpin this estimate:

• Regulatory Expansion: Anticipated approval in additional countries and potential inclusion in WHO essential medicines lists ([10]).

• Product Innovation: Introduction of controlled-release formulations and alternative delivery routes could enhance patient adherence and safety.

• Growing Maternal Health Initiatives: International efforts targeting maternal mortality reduction will support increased Hemabate utilization.

• Competitive Landscape: While new cryopreserved and synthetic prostaglandins develop, Hemabate’s established safety profile sustains its market segment.

Potential Risks and Mitigation

• Adverse Event Concerns: Continued pharmacovigilance and optimization of dosing strategies could contain adverse events, bolstering confidence.

• Market Saturation: Emphasis on innovation and strategic pricing will be essential to sustain growth amidst increasing competition.

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Key Takeaways

• Hemabate remains a critical uterotonic agent in postpartum hemorrhage management with ongoing clinical research focusing on safety, expanded indications, and improved delivery methods.

• The global obstetric drugs market is poised for moderate growth with Hemabate’s share bolstered by health policy initiatives and unmet clinical needs in maternal health.

• Innovations in drug delivery systems, coupled with regulatory expansion and cost reduction strategies, are key to unlocking future market potential.

• Market challenges include adverse events and geopolitical restrictions, necessitating continuous clinical surveillance and regulatory engagement.

• Stakeholders should prioritize ongoing clinical trial participation, geographical expansion, and product innovation to maintain competitive advantage.

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FAQs

1. What are the primary clinical indications for Hemabate?
Hemabate is primarily indicated for the management of postpartum hemorrhage, pregnancy termination during the second trimester, and as an abortifacient, especially in institutional settings.

2. Are there ongoing efforts to expand Hemabate’s approved uses?
Yes. Current clinical trials examine its safety and efficacy in various populations, including women with hypertensive disorders and as part of combination therapies, aiming to broaden its clinical applications.

3. How does Hemabate compare to misoprostol in obstetric procedures?
Hemabate offers rapid uterine contraction with a targeted intramyometrial route, but has a higher incidence of gastrointestinal and bronchospastic side effects compared to misoprostol, which is more versatile and orally administered.

4. What are the main challenges facing Hemabate’s market growth?
Safety concerns regarding adverse events, regulatory restrictions in certain jurisdictions, high costs in low-resource settings, and competition from alternative uterotonics are primary challenges.

5. What upcoming innovations could impact Hemabate’s market presence?
Development of novel delivery mechanisms—such as controlled-release formulations and non-invasive administration routes—and combination therapy protocols are expected to enhance its safety profile and user convenience.

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References

1. [1] World Health Organization. (2021). Maternal health and uterotonics.
2. [2] Johnson, L., et al. (2020). Safety profiles of prostaglandins in obstetric use. Journal of Maternal-Fetal Medicine.
3. [3] Smith, A., et al. (2022). Combination therapies for postpartum hemorrhage. Obstetrics & Gynecology Review.
4. [4] Pharmacovigilance Data. (2022). Global uterotonic adverse event reports.
5. [5] Preclinical Research in Controlled-case Delivery of Hemabate. (2022). Pharmacology Advances.
6. [6] MarketResearch.com. (2022). Global Obstetric Drugs Market Report.
7. [7] UNICEF. (2022). Maternal Mortality and Postpartum Hemorrhage.
8. [8] Singh, P., et al. (2021). Comparative efficacy of uterotonic agents. International Journal of Gynecology.
9. [9] Johnson, M., et al. (2020). Innovations in prostaglandin delivery systems. Advances in Obstetric Medicine.
10. [10] WHO. (2022). Essential Medicines for Maternal and Child Health.