Twin; Complicating PregnancyPhase 4NCT05772156
Prophylactic Methylergonovine for Twin Cesarean
A Phase 4 study testing Methylergonovine in people with Twin; Complicating Pregnancy and Postpartum Hemorrhage, run by Columbia University at 1 site in United States.
Trial summary
Obstetrical hemorrhage (excessive bleeding related to pregnancy) is a leading cause of maternal morbidity (disease or symptom of disease) and mortality (death) worldwide with a significantly higher frequency and severity following cesarean delivery. Read more about this study
- Who is it for?
- Ages Up to 65 years, women only
- Conditions the study is for
- Twin; Complicating Pregnancy, Postpartum Hemorrhage
- What is being tested?
- Methylergonovine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2023to 11 Mar 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Twin gestation
- Scheduled cesarean delivery (>=34 weeks)
Who cannot join
- Patients with known hypertensive disease: history of chronic hypertension, gestational hypertension or preeclampsia with or without severe features
- Use of protease inhibitors given known vasoconstrictive side effects with concomitant methylergonovine administration
- Hypersensitivity to methylergonovine or any of the ingredients
- Participating in another intervention study where the primary outcome includes postpartum bleeding or thromboembolism, or the study intervention directly affects postpartum bleeding or thromboembolism
- Receipt of uterotonics, other than oxytocin, or planned or expected use of uterotonic prophylaxis
- Non-elective cesarean delivery
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Prophylactic Methylergonovine in Patients Undergoing Cesarean Delivery With Twin Gestations: A Randomized Controlled Trial
Obstetrical hemorrhage (excessive bleeding related to pregnancy) is a leading cause of maternal morbidity (disease or symptom of disease) and mortality (death) worldwide with a significantly higher frequency and severity following cesarean delivery. Twin gestations (twin pregnancy) are at particularly higher risk for postpartum hemorrhage, yet the management of obstetrical bleeding following twin delivery remains identical to singleton delivery.
The purpose of this study is to understand the effect of prophylactic methylergonovine on blood loss in scheduled twin pregnancy cesarean deliveries. Participants will be randomized (like tossing a coin) to Methylergonovine (investigational drug) or water with salt (saline) (placebo). Methylergonovine or saline will be given as an injection immediately after delivery.
Read the detailed description
Obstetrical hemorrhage is a leading cause of maternal morbidity and mortality worldwide with a significantly higher frequency and severity following cesarean delivery. In 2020, 31.9 percent of pregnant women in the United States underwent cesarean delivery, making it the second most common operation performed. Though multiple complications can occur following cesarean delivery, hemorrhage morbidities are among the most common with significant cardiovascular implications. Twin gestations are at particularly higher risk for postpartum hemorrhage due to impaired myometrial contractility and atony following overdistention; increased maternal blood volume; and increased uterine blood flow compared to singletons, yet the management of obstetrical bleeding following twin delivery remains identical to singleton delivery. Current strategies to address intrapartum hemorrhage have relied on pharmacological and mechanical treatments after intraoperative identification. However, there is extensive work on prophylactic therapies administered intraoperatively to prevent obstetrical hemorrhage. Recent evidence has emerged about the utility of prophylactic Methylergonovine for the prevention of obstetrical hemorrhage. Methylergonovine, a semisynthetic ergot alkaloid, acts primarily on alpha adrenergic receptors of uterine and vascular smooth muscle, increasing uterine tone and promoting vasoconstriction. In a randomized trial of 80 women undergoing intrapartum cesarean delivery found that fewer patients who were allocated to the methylergonovine group received additional uterotonic agents (20% vs 55%, relative risk (RR) 0.4, 95% confidence interval (CI) 0.2-0.6). Participants receiving methylergonovine were more likely to have satisfactory uterine tone (80% vs 41%, RR 1.9, 95% CI 1.5-2.6), lower incidence of postpartum hemorrhage (35% vs 59%, RR 0.6, 95% CI 0.4-0.9), lower mean quantitative blood loss (967 mL vs 1,315 mL; mean difference 348, 95% CI 124-572), and a lower frequency of blood transfusion (5% vs 23%, RR 0.2, 95% CI 0.1-0.6). Investigators concluded that the administration of prophylactic methylergonovine in addition to oxytocin in patients undergoing intrapartum cesarean birth reduces the need for additional uterotonic agents. In a prospective study of 1210 participants found that intraoperative, prophylactic methylergonovine decreased post-operative blood loss with no adverse side effects. Randomized trials of Methylergonovine as prophylaxis to prevent hemorrhage in cesarean delivery have exclude twin gestations. Currently, there remains a paucity of research regarding prophylactic procedures for twin cesarean delivery. There is an opportunity to prophylactically address hemorrhage in high-risk groups. Therefore, the investigators propose a prospective randomized controlled trial which will compare maternal blood loss associated with prophylactic methylergonovine during cesarean delivery among patients with twin.
- Being tested
- Methylergonovine, Placebo
- Medical subject headings
- Pregnancy Complications, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylergonovineDrug
Also called Methergine
Methylergonovine 200mcg Intramuscular (IM)
PlaceboDrug
Also called Saline
Matching saline placebo
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic methylergonovine | Experimental | Prophylactic methylergonovine 200mcg IM Receives: Drug: Methylergonovine |
| Control group/placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maternal Hemoglobin Level
The change in maternal hemoglobin level as taken from blood samples. The change will be calculated from preoperative day 1 (baseline) to postoperative day 1.
Measured: Baseline and Postoperative Day 1 (Approximately 48 hours)
Secondary outcomes (18)
Surgical Time
Surgical time measured from the time of incision to closure
Measured: Intraoperative (Approximately 24 hours)
Estimated Blood Loss
At the end of the surgery, the primary surgeon will estimate the blood loss throughout the case.
Measured: Intraoperative (Approximately 24 hours)
Quantitative Blood Loss
Quantitative blood loss is calculated by weighing the used towels during the operation. The number is calculated by the circulating nurse in the operating room.
Measured: Intraoperative (Approximately 24 hours)
Number of Participants With Postpartum Hemorrhage
The number of participants with postpartum hemorrhage (defined as estimated blood loss >1000 cc)
Measured: Intraoperative (Approximately 24 hours)
Number of Participants Requiring Use of Uterotonics
Number of participants given uterotonics, such as prostaglandins
Measured: Intraoperative (Approximately 24 hours)
Number of Participants Requiring Use of Tranexamic Acid
Number of participants given Tranexamic acid
Measured: Intraoperative (Approximately 24 hours)
Number of Participants Requiring Use of Open-Label Methylergonovine
Number of participants requiring the use of any amount of open-label methylergonovine (not blinded study drug)
Measured: Intraoperative (Approximately 24 hours)
Number of Participants Requiring Transfusion (Intraoperative)
Number of participants requiring transfusion of 1 or more units of packed red blood cells, including whole blood or cell saver.
Measured: Intraoperative (Approximately 24 hours)
Number of Participants With Surgical or Radiological Interventions
Composite number of surgical or radiological interventions (such as: laparotomy, evacuation of hematoma, hysterectomy, uterine packing, intrauterine balloon tamponade, interventional radiology) to control bleeding and related complications or maternal death.
Measured: Intraoperative (Approximately 24 hours)
Number of Participants With Transfusion Related Acute Lung Injury (TRALI)
Number of participants with transfusion related acute lung injury (TRALI)
Measured: 6 weeks
Number of Participants Requiring Transfusion (6 Weeks)
Number of participants requiring transfusion of 1 or more units of fresh frozen plasma, cryoprecipitate, or platelets or administration of any factor concentrates.
Measured: 6 weeks
Number of Participants With Acute Elevation of Serum Creatinine
Number of participants with acute elevation of serum creatinine of ≥ 0.3 mg/dL
Measured: 48 hours
Number of Postpartum Infectious Complications
Number of Postpartum infectious complications such as: endometritis, surgical site infection, pelvic abscess
Measured: 6 weeks
Number of Participants With Admission to the Intensive Care Unit
Number of participants with admission to the intensive care unit for more than 24 hours
Measured: 6 weeks
Length of Stay
Length of stay measured from the time of hospital admission to hospital discharge.
Measured: Up to 6 weeks
Number of Participants Re-Admitted to the Hospital
The number of participants who experienced hospital re-admission
Measured: 6 weeks
Apgar Scores
Apgar score is a measure of the physical condition of a newborn infant. Scores range from 0-10 with a higher score indicating a better outcome; Apgar score of 0-3 is low, 4-6 is moderately abnormal, and 7-10 is reassuring.
Measured: 1 and 5 minutes post-delivery (approximately 24 hours post-baseline)
Neonatal Intensive Care Unit (NICU) Admission
Number of newborns admitted to the neonatal intensive care unit (NICU).
Measured: Time of delivery (Approximately 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start7 Mar 2023
- Primary completion3 Mar 2024
- Study completion11 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Twin; Complicating PregnancyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirella Mourad, Columbia University
- Investigators
- Mirella Mourad, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772156
- Sponsor's protocol ID
- AAAU3902
- Status last verified
- May 2025
- First submitted
- 6 Mar 2023
- Last updated
- 13 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is currently undecided if the Individual participant data (IPD) will be shared. If there is a plan to share the following will be shared: the IPD that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices), the Study Protocol, Statistical Analysis Plan, and, Informed Consent Form documents. The timeframe for which the IPD will be shared is beginning 3 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal, so that they may achieve aims in the proposal.
Publications
Osterman M, Hamilton B, Martin JA, Driscoll AK, Valenzuela CP. Births: Final Data for 2020. Natl Vital Stat Rep. 2021 Feb;70(17):1-50.
PubMed 35157571Sheehan SR, Montgomery AA, Carey M, McAuliffe FM, Eogan M, Gleeson R, Geary M, Murphy DJ; ECSSIT Study Group. Oxytocin bolus versus oxytocin bolus and infusion for control of blood loss at elective caesarean section: double blind, placebo controlled, randomised trial. BMJ. 2011 Aug 1;343:d4661. doi: 10.1136/bmj.d4661.
PubMed 21807773Blitz MJ, Yukhayev A, Pachtman SL, Reisner J, Moses D, Sison CP, Greenberg M, Rochelson B. Twin pregnancy and risk of postpartum hemorrhage. J Matern Fetal Neonatal Med. 2020 Nov;33(22):3740-3745. doi: 10.1080/14767058.2019.1583736. Epub 2019 Mar 5.
PubMed 30836810Attilakos G, Psaroudakis D, Ash J, Buchanan R, Winter C, Donald F, Hunt LP, Draycott T. Carbetocin versus oxytocin for the prevention of postpartum haemorrhage following caesarean section: the results of a double-blind randomised trial. BJOG. 2010 Jul;117(8):929-36. doi: 10.1111/j.1471-0528.2010.02585.x. Epub 2010 May 19.
PubMed 20482535Chaudhuri P, Banerjee GB, Mandal A. Rectally administered misoprostol versus intravenous oxytocin infusion during cesarean delivery to reduce intraoperative and postoperative blood loss. Int J Gynaecol Obstet. 2010 Apr;109(1):25-9. doi: 10.1016/j.ijgo.2009.11.009. Epub 2010 Jan 13.
PubMed 20070961Senturk S, Kagitci M, Balik G, Arslan H, Kir Sahin F. The Effect of the Combined Use of Methylergonovine and Oxytocin during Caesarean Section in the Prevention of Post-partum Haemorrhage. Basic Clin Pharmacol Toxicol. 2016 May;118(5):338-43. doi: 10.1111/bcpt.12500. Epub 2015 Nov 15.
PubMed 26449959Masse N, Dexter F, Wong CA. Prophylactic Methylergonovine and Oxytocin Compared With Oxytocin Alone in Patients Undergoing Intrapartum Cesarean Birth: A Randomized Controlled Trial. Obstet Gynecol. 2022 Aug 1;140(2):181-186. doi: 10.1097/AOG.0000000000004857. Epub 2022 Jul 6.
PubMed 35852267Horowitz E, Yogev Y, Ben-Haroush A, Rabinerson D, Feldberg D, Kaplan B. Routine hemoglobin testing following an elective Cesarean section: is it necessary? J Matern Fetal Neonatal Med. 2003 Oct;14(4):223-5. doi: 10.1080/jmf.14.4.223.225.
PubMed 14738165
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Methylergonovine in Patients Undergoing Cesarean Delivery With Twin Gestations: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05772156
- Acronym / sponsor ID
- AAAU3902
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 3 Mar 2024 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Posted 13 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstetrical hemorrhage (excessive bleeding related to pregnancy) is a leading cause of maternal morbidity (disease or symptom of disease) and mortality (death) worldwide with a significantly higher frequency and severity following cesarean delivery. Twin gestations (twin pregnancy) are at particularly higher risk for postpartum hemorrhage, yet the management of obstetrical bleeding following twin delivery remains identical to singleton delivery.
The purpose of this study is to understand the effect of prophylactic methylergonovine on blood loss in scheduled twin pregnancy cesarean deliveries. Participants will be randomized (like tossing a coin) to Methylergonovine (investigational drug) or water with salt (saline) (placebo). Methylergonovine or saline will be given as an injection immediately after delivery.
Detailed description
Obstetrical hemorrhage is a leading cause of maternal morbidity and mortality worldwide with a significantly higher frequency and severity following cesarean delivery. In 2020, 31.9 percent of pregnant women in the United States underwent cesarean delivery, making it the second most common operation performed. Though multiple complications can occur following cesarean delivery, hemorrhage morbidities are among the most common with significant cardiovascular implications. Twin gestations are at particularly higher risk for postpartum hemorrhage due to impaired myometrial contractility and atony following overdistention; increased maternal blood volume; and increased uterine blood flow compared to singletons, yet the management of obstetrical bleeding following twin delivery remains identical to singleton delivery. Current strategies to address intrapartum hemorrhage have relied on pharmacological and mechanical treatments after intraoperative identification. However, there is extensive work on prophylactic therapies administered intraoperatively to prevent obstetrical hemorrhage. Recent evidence has emerged about the utility of prophylactic Methylergonovine for the prevention of obstetrical hemorrhage. Methylergonovine, a semisynthetic ergot alkaloid, acts primarily on alpha adrenergic receptors of uterine and vascular smooth muscle, increasing uterine tone and promoting vasoconstriction. In a randomized trial of 80 women undergoing intrapartum cesarean delivery found that fewer patients who were allocated to the methylergonovine group received additional uterotonic agents (20% vs 55%, relative risk (RR) 0.4, 95% confidence interval (CI) 0.2-0.6). Participants receiving methylergonovine were more likely to have satisfactory uterine tone (80% vs 41%, RR 1.9, 95% CI 1.5-2.6), lower incidence of postpartum hemorrhage (35% vs 59%, RR 0.6, 95% CI 0.4-0.9), lower mean quantitative blood loss (967 mL vs 1,315 mL; mean difference 348, 95% CI 124-572), and a lower frequency of blood transfusion (5% vs 23%, RR 0.2, 95% CI 0.1-0.6). Investigators concluded that the administration of prophylactic methylergonovine in addition to oxytocin in patients undergoing intrapartum cesarean birth reduces the need for additional uterotonic agents. In a prospective study of 1210 participants found that intraoperative, prophylactic methylergonovine decreased post-operative blood loss with no adverse side effects. Randomized trials of Methylergonovine as prophylaxis to prevent hemorrhage in cesarean delivery have exclude twin gestations. Currently, there remains a paucity of research regarding prophylactic procedures for twin cesarean delivery. There is an opportunity to prophylactically address hemorrhage in high-risk groups. Therefore, the investigators propose a prospective randomized controlled trial which will compare maternal blood loss associated with prophylactic methylergonovine during cesarean delivery among patients with twin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic methylergonovine | Experimental | Drug: MethylergonovineProphylactic methylergonovine 200mcg IM |
| Control group/placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- Up to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Twin gestation
- Scheduled cesarean delivery (>=34 weeks)
Key exclusion criteria (6 listed)
- Patients with known hypertensive disease: history of chronic hypertension, gestational hypertension or preeclampsia with or without severe features
- Use of protease inhibitors given known vasoconstrictive side effects with concomitant methylergonovine administration
- Hypersensitivity to methylergonovine or any of the ingredients
- Participating in another intervention study where the primary outcome includes postpartum bleeding or thromboembolism, or the study intervention directly affects postpartum bleeding or thromboembolism
- Receipt of uterotonics, other than oxytocin, or planned or expected use of uterotonic prophylaxis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylergonovineAlso: MethergineMethylergonovine 200mcg Intramuscular (IM) | Drug | Prophylactic methylergonovine |
| PlaceboAlso: SalineMatching saline placebo | Drug | Control group/placebo |
Primary outcome
Change in Maternal Hemoglobin Level
Time frame: Baseline and Postoperative Day 1 (Approximately 48 hours)
The change in maternal hemoglobin level as taken from blood samples. The change will be calculated from preoperative day 1 (baseline) to postoperative day 1.
18 secondary outcomes
Surgical Time
Time frame: Intraoperative (Approximately 24 hours)
Estimated Blood Loss
Time frame: Intraoperative (Approximately 24 hours)
Quantitative Blood Loss
Time frame: Intraoperative (Approximately 24 hours)
Number of Participants With Postpartum Hemorrhage
Time frame: Intraoperative (Approximately 24 hours)
Number of Participants Requiring Use of Uterotonics
Time frame: Intraoperative (Approximately 24 hours)
Number of Participants Requiring Use of Tranexamic Acid
Time frame: Intraoperative (Approximately 24 hours)
Number of Participants Requiring Use of Open-Label Methylergonovine
Time frame: Intraoperative (Approximately 24 hours)
Number of Participants Requiring Transfusion (Intraoperative)
Time frame: Intraoperative (Approximately 24 hours)
Number of Participants With Surgical or Radiological Interventions
Time frame: Intraoperative (Approximately 24 hours)
Number of Participants With Transfusion Related Acute Lung Injury (TRALI)
Time frame: 6 weeks
Number of Participants Requiring Transfusion (6 Weeks)
Time frame: 6 weeks
Number of Participants With Acute Elevation of Serum Creatinine
Time frame: 48 hours
Number of Postpartum Infectious Complications
Time frame: 6 weeks
Number of Participants With Admission to the Intensive Care Unit
Time frame: 6 weeks
Length of Stay
Time frame: Up to 6 weeks
Number of Participants Re-Admitted to the Hospital
Time frame: 6 weeks
Apgar Scores
Time frame: 1 and 5 minutes post-delivery (approximately 24 hours post-baseline)
Neonatal Intensive Care Unit (NICU) Admission
Time frame: Time of delivery (Approximately 24 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35157571Osterman M, Hamilton B, Martin JA, Driscoll AK, Valenzuela CP. Births: Final Data for 2020. Natl Vital Stat Rep. 2021 Feb;70(17):1-50.
- Background: PubMed 21807773Sheehan SR, Montgomery AA, Carey M, McAuliffe FM, Eogan M, Gleeson R, Geary M, Murphy DJ; ECSSIT Study Group. Oxytocin bolus versus oxytocin bolus and infusion for control of blood loss at elective caesarean section: double blind, placebo controlled, randomised trial. BMJ. 2011 Aug 1;343:d4661. doi: 10.1136/bmj.d4661.
- Background: PubMed 30836810Blitz MJ, Yukhayev A, Pachtman SL, Reisner J, Moses D, Sison CP, Greenberg M, Rochelson B. Twin pregnancy and risk of postpartum hemorrhage. J Matern Fetal Neonatal Med. 2020 Nov;33(22):3740-3745. doi: 10.1080/14767058.2019.1583736. Epub 2019 Mar 5.
- Background: PubMed 20482535Attilakos G, Psaroudakis D, Ash J, Buchanan R, Winter C, Donald F, Hunt LP, Draycott T. Carbetocin versus oxytocin for the prevention of postpartum haemorrhage following caesarean section: the results of a double-blind randomised trial. BJOG. 2010 Jul;117(8):929-36. doi: 10.1111/j.1471-0528.2010.02585.x. Epub 2010 May 19.
- Background: PubMed 20070961Chaudhuri P, Banerjee GB, Mandal A. Rectally administered misoprostol versus intravenous oxytocin infusion during cesarean delivery to reduce intraoperative and postoperative blood loss. Int J Gynaecol Obstet. 2010 Apr;109(1):25-9. doi: 10.1016/j.ijgo.2009.11.009. Epub 2010 Jan 13.
- Background: PubMed 26449959Senturk S, Kagitci M, Balik G, Arslan H, Kir Sahin F. The Effect of the Combined Use of Methylergonovine and Oxytocin during Caesarean Section in the Prevention of Post-partum Haemorrhage. Basic Clin Pharmacol Toxicol. 2016 May;118(5):338-43. doi: 10.1111/bcpt.12500. Epub 2015 Nov 15.
- Background: PubMed 35852267Masse N, Dexter F, Wong CA. Prophylactic Methylergonovine and Oxytocin Compared With Oxytocin Alone in Patients Undergoing Intrapartum Cesarean Birth: A Randomized Controlled Trial. Obstet Gynecol. 2022 Aug 1;140(2):181-186. doi: 10.1097/AOG.0000000000004857. Epub 2022 Jul 6.
- Background: PubMed 14738165Horowitz E, Yogev Y, Ben-Haroush A, Rabinerson D, Feldberg D, Kaplan B. Routine hemoglobin testing following an elective Cesarean section: is it necessary? J Matern Fetal Neonatal Med. 2003 Oct;14(4):223-5. doi: 10.1080/jmf.14.4.223.225.
- Individual participant dataSharing planned: Undecided. It is currently undecided if the Individual participant data (IPD) will be shared. If there is a plan to share the following will be shared: the IPD that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices), the Study Protocol, Statistical Analysis Plan, and, Informed Consent Form documents. The timeframe for which the IPD will be shared is beginning 3 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal, so that they may achieve aims in the proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirella Mourad principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylergonovine in people with Twin; Complicating Pregnancy and Postpartum Hemorrhage, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maternal Hemoglobin Level (time frame: Baseline and Postoperative Day 1 (Approximately 48 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05772156, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.