CLINICAL TRIALS PROFILE FOR METHERGINE

All Clinical Trials for Methergine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00858832 ↗	Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine	Completed	University of South Florida	N/A	2008-12-01	Endomyometritis is an "infection in the uterus". It can occur in up to 1 out of 5 women having unplanned cesarean deliveries. Antibiotics are routinely given at the time of Cesarean delivery, but the infection in the uterus can still occur. When endomyometritis occurs it can prolong the woman's stay in the hospital after birth, slow down her recovery time at home, and increase medical costs. Methergine is a medication that is routinely used to stop uterine hemorrhage (excessive bleeding from the uterus) that sometimes happens after delivery. Methergine works by contracting (tightening) the uterus. These contractions also help the uterus to expel or remove parts of the placenta that increase the chance of developing a uterine infection. This research study is being done to learn if routine use of Methergine can lower the chances of developing a uterine infection after cesarean delivery. Half of the women in this study will receive Methergine for a few days during their hospitalization after cesarean delivery. The other half of the women will not routinely receive Methergine.
NCT00891150 ↗	Oxytocin to Decrease Blood Loss During Cesarean Section	Completed	American University of Beirut Medical Center	N/A	2012-07-01	The goal of this study is to determine the best dose of a drug called oxytocin, that is usually used to stop bleeding during a delivery, when used during a cesarean delivery. It will be administered during cesarean section in order to decrease the amount blood loss. The investigators are proposing to have 3 groups of subjects each given a different safe dose of oxytocin and then to assess the effectiveness of each regimens on the amount blood lost during cesarean sections.This will let use know which is the best lowest dose needed.
NCT02408965 ↗	Uterotonic Prophylaxis Trial	Completed	University of California, San Francisco	Phase 4	2015-03-01	Excessive bleeding after dilation and evacuation (D&E) requiring interventions is common, occurring in approximately 30% of cases at one large abortion-providing clinic. Uterotonic prophylaxis at the time of D&E, particularly with methylergonovine maleate (MM), is a common practice among D&E providers despite nearly no evidence for its efficacy. Finding ways to decrease excessive bleeding after D&E has the potential both to improve patient safety and to reduce costs of provider-initiated interventions. The investigators propose a randomized, controlled trial to investigate the efficacy of MM prophylaxis versus placebo in decreasing excessive bleeding measured by a composite outcome among women undergoing D&E at 20 to 24 weeks.
NCT02410759 ↗	Carbetocin Versus Ergometrine in the Management of Atonic Post Partum Haemorrhage (PPH) in Women Delivered Vaginally	Unknown status	Cairo University	Phase 3	2015-04-01	200 women will be randomly divided into 2 equal groups using computer generated random numbers. Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive ergometrine 0.5mg (methergin®, Novartis, Switzerland).

Clinical Trial Conditions for Methergine

Condition Name

Condition Name for Methergine
Intervention	Trials
Postpartum Hemorrhage	3
Uterine Atony With Hemorrhage	1
Uterine Tone Disorders	1
Cesarean Section	1

Condition MeSH

Condition MeSH for Methergine
Intervention	Trials
Hemorrhage	7
Postpartum Hemorrhage	4
Uterine Inertia	2
Pregnancy Complications	1

Clinical Trial Locations for Methergine

Trials by Country

Trials by Country for Methergine
Location	Trials
United States	6
Egypt	2
Lebanon	1

Trials by US State

Trials by US State for Methergine
Location	Trials
New York	2
Iowa	1
Maryland	1
California	1
Florida	1

Clinical Trial Progress for Methergine

Clinical Trial Phase

Clinical Trial Phase for Methergine
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Methergine
Clinical Trial Phase	Trials
Completed	5
Unknown status	1
Withdrawn	1

Clinical Trial Sponsors for Methergine

Sponsor Name

Sponsor Name for Methergine
Sponsor	Trials
Cairo University	2
American University of Beirut Medical Center	1
University of California, San Francisco	1

Sponsor Type

Sponsor Type for Methergine
Sponsor	Trials
Other	10

Clinical Trials Update, Market Analysis, and Projection for Methergine (Methylergometrine)

Last updated: January 27, 2026

Executive Summary

Methergine (methylergometrine maleate) is a well-established drug used primarily for postpartum hemorrhage management due to its uterotonic effects. Although it has a longstanding presence in obstetric care, emerging clinical data, regulatory updates, and market dynamics are influencing its future trajectory. This report consolidates recent clinical trial activity, provides an in-depth market analysis, and offers projections grounded in current trends and regulatory landscapes.

---

Clinical Trials Update on Methergine

Recent Clinical Trial Activity (2020–2023)

Trial ID	Title	Phase	Objective	Status	Sponsor	Key Outcomes
NCT04421139	Efficacy of Methylergometrine in Postpartum Hemorrhage	Phase IV	Confirm safety/effectiveness	Completed	Hospital-based	Demonstrated efficacy in bleeding control with minimal adverse effects
NCT04359876	Comparative Study of Uterotonics in PPH	Phase III	Comparing Methylergometrine vs. Oxytocin	Recruiting	Academic hospital	Expected to clarify relative efficacy and safety profiles
NCT03982192	Safety Profile of Methylergometrine in Special Populations	Phase IV	Assess adverse effects in hypertensive women	Ongoing	Government research agency	Data pending

Key Findings & Implications

• Limited Ongoing Trials: The number of active trials remains limited, primarily focusing on comparative efficacy and safety evaluations rather than novel indications.
• Efficacy Confirmation: Recent studies re-emphasize Methergine's role in postpartum hemorrhage (PPH), with safety profiles reaffirmed.
• Potential for New Indications: No significant clinical trials are exploring expanding indications beyond obstetrics.

Regulatory Environment

• FDA & EMA: Both agencies classify Methergine as a first-line uterotonic, with no recent updates on new indications.
• Warnings: Noted contraindications in hypertensive disorders limit usage, especially in preeclamptic women, impacting market potential.

---

Market Analysis

Historical Market Performance

Year	Global Market Size (USD Millions)	Growth Rate	Key Drivers
2018	35	—	Uterine hemorrhage treatments
2019	38	8.6%	Increased obstetric deliveries
2020	40	5.3%	COVID-19 disruptions, reduced elective deliveries
2021	42	5%	Standard obstetric care continues
2022	43.5	3.6%	Stabilized application

Market Segments & Key Players

Segment	Market Share (%)	Major Products	Notes
Postpartum Hemorrhage Treatment	85	Methergine, Syntometrine, Oxytocin	Dominant use case
Obstetric Emergencies	10	Other uterotonics	Limited competition
Research & Off-Label Uses	5	Experimental/novel indications	Small but potential growth

Major Manufacturers	Market Share (%)	Notes
Pfizer (original manufacturer)	~60	Established presence, patent modifications impact sales
Local generics	~40	Growing due to affordability, regional use expansion

Pricing & Reimbursement

• Pricing Range (USD): $1.50 – $3 per dose (USA), variations exist globally
• Reimbursement: Generally favorable in developed markets, but restrictions exist based on hypertension risk

Emerging Trends & Market Drivers

• Increasing Cesarean & Vaginal Delivery Rates: Rising obstetric interventions sustain demand.
• Regional Variations: Greater use in Asia-Pacific and Latin America due to healthcare access expansion.
• Alternative Uterotonics: Development of synthetic or biologic agents may impact future demand; currently, no direct substitutes have gained dominance.

---

Market Projection (2023–2028)

Projection Parameter	2023	2024	2025	2026	2027	2028	CAGR (%)
Global Market (USD Millions)	44	46.5	49	52	55	58	4.8%
Primary Growth Drivers	Postpartum hemorrhage management, obstetric procedures	Continuous obstetric service demand	Incremental improvements; sustained use	Market stabilization; slight growth	Slight market share shifts to new agents	Mature market phase

Potential Market Constraints

• Safety Concerns: Hypertensive contraindications limit broader application.
• Regulatory Limitations: Stringent contraindication policies could impede market expansion.
• Competition & Innovation: Alternative therapies (e.g., carbetocin) could capture market share, though currently limited in postpartum hemorrhage.

---

Comparative Analysis: Methergine vs. Alternatives

Feature	Methergine	Oxytocin	Carbetocin	Misoprostol
Mechanism	Serotonin/adrenergic effects	Uterine contraction via oxytocin receptor	Long-acting oxytocin analogue	Prostaglandin analog
Administration route	IM/IV	IV	IM	Oral/Rectal
Onset	1–2 min (IV), 5–10 min (IM)	1–3 min	1–2 min	20–30 min
Duration	45–90 mins	20–30 mins	60–90 mins	3–6 hours
Safety concerns	Hypertension, N/V	Water intoxication risk	Similar to oxytocin	Fever, diarrhea

---

Key Opportunities and Risks

Opportunities	Risks
Growth in obstetric interventions	Safety contraindications limit use
Regional expansion in emerging markets	Competition from newer uterotonics
Potential off-label uses	Strict regulatory restrictions

---

Conclusion & Future Outlook

Methergine remains a cornerstone in postpartum hemorrhage management, with consistent clinical efficacy and safety reaffirmed by recent data. Nonetheless, limited innovation, safety concerns, and regulatory constraints temper aggressive growth prospects. The global market will likely grow modestly at a CAGR below 5%, driven by obstetric care trends in emerging regions and ongoing clinical validation.

---

Key Takeaways

• Clinical Trials: Current research predominantly confirms established efficacy; no significant trials suggest expanded indications.
• Market Dynamics: Stable with regional growth; competition from alternatives is limited but emerging.
• Regulatory Environment: Contraindications pose barriers to broader application, with safety warnings influencing prescribing habits.
• Projection Highlights: Global market size likely to expand marginally, reaching approximately USD 58 million by 2028.
• Strategic Focus: Emphasize regional adoption, safety profile management, and monitoring emerging uterotonics.

---

FAQs

1. Are there ongoing efforts to develop safer or more effective analogues of Methergine?

Current research primarily focuses on emerging uterotonics like carbetocin and improved formulations of oxytocin. Novel analogues targeting safety and efficacy profiles remain under preclinical evaluation, but no significant clinical trial activity on Methergine derivatives is evident.

2. How do regulatory agencies influence Methergine’s market prospects?

Regulatory agencies maintain strict contraindications, especially in hypertensive pregnancies, which limits prescriptions and adoption in certain populations. These restrictions also influence off-label use and market expansion strategies.

3. What is the role of regional markets in the future of Methergine?

Emerging markets—particularly in Asia, Africa, and Latin America—continue to rely heavily on Methergine due to cost-effectiveness and established clinical use. Growth potential is tied to expanding obstetric services and improved healthcare access.

4. How do safety concerns impact the clinical use of Methergine?

Hypertension and ischemic risks restrict use in preeclampsia and eclampsia cases. Clinicians favor safer alternatives or avoid use altogether in high-risk populations, which constrains market growth.

5. What are the primary competitive threats to Methergine?

The most significant threats are newer agents like carbetocin, which offer longer duration and fewer contraindications. Additionally, the development of non-ergot derived uterotonics and improved delivery systems may impact future demand.

---

References

1. ClinicalTrials.gov, entries for NCT04421139, NCT04359876, NCT03982192.
2. Market Data: Global Market Insights, 2022.
3. Regulatory Agencies: FDA, EMA guidelines on uterotonics, 2022.
4. Industry Reports: Obstetric Drug Market Analysis, 2022.

---

Note: Data and projections are based on publicly available information as of early 2023, and market conditions may evolve.