Monochorionic Diamniotic PlacentaNCT05543499
Database of Monochorionic Pregnancies
An observational study of Monochorionic Diamniotic Placenta and Monochorial Monoamniotic Placenta, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to collect and analyze data regarding natural history, indications for fetal interventions, and maternal and fetal/neonatal outcomes associated with complicated monochorionic twin pregnancy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Monochorionic Diamniotic Placenta, Monochorial Monoamniotic Placenta, Twin; Complicating Pregnancy
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to 1 Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of Monochorionic pregnancies (maternal, fetal, and neonatal data) that have undergone evaluation and/or treatment for complications attributable to monochorionic twin pregnancy at the University of Miami.
Who may be able to join
- The study population will consist of MC pregnancies (maternal, fetal, and neonatal data) that have undergone evaluation and/or treatment for complications attributable to monochorionic twin pregnancy at the University of Miami.
- Maternal age 18 years and older.
Who cannot join
- Participation declined or consent not granted in prospective arm
- Loss to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standardized Prenatal Management and Perinatal Outcome of Complicated Monochorionic Pregnancies
The purpose of this study is to collect and analyze data regarding natural history, indications for fetal interventions, and maternal and fetal/neonatal outcomes associated with complicated monochorionic twin pregnancy.
- Conditions
- Monochorionic Diamniotic Placenta, Monochorial Monoamniotic Placenta, Twin; Complicating Pregnancy, Twin to Twin Transfusion Syndrome, Twin Reversal Arterial Perfusion Syndrome
- Keywords
- multiple pregnancies, Twins
- Medical subject headings
- Pregnancy Complications, Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Monochorionic Pregnancy Group | Participants with complicated monochorionic pregnancies (MC) will be followed prospectively beginning at the time of the mother's evaluation for a complication related to monochorionic (MC) multiple pregnancies through delivery of the child and follow-up of the child to 12 months of life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Preterm Delivery
Preterm delivery is defined as birth <37 weeks gestation
Measured: Up to 42 weeks gestation
Number of participant with Premature Spontaneous Rupture of the Membranes
As per clinical evaluation
Measured: Up to 42 weeks
Number of Infant Deaths
The Number of Infant Deaths
Measured: Up to 12 months post infant delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Oct 2022
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monochorionic Diamniotic PlacentaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Ruano, University of Miami
- Investigators
- Rodrigo Ruano, MD PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543499
- Sponsor's protocol ID
- 20210709
- Status last verified
- May 2026
- First submitted
- 14 Sep 2022
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Prenatal Management and Perinatal Outcome of Complicated Monochorionic Pregnancies
- ClinicalTrials.gov ID
- NCT05543499
- Acronym / sponsor ID
- 20210709
- Conditions
- Monochorionic Diamniotic Placenta, Monochorial Monoamniotic Placenta, Twin; Complicating Pregnancy, Twin to Twin Transfusion Syndrome, Twin Reversal Arterial Perfusion Syndrome
- Keywords
- multiple pregnancies, Twins
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect and analyze data regarding natural history, indications for fetal interventions, and maternal and fetal/neonatal outcomes associated with complicated monochorionic twin pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monochorionic Pregnancy Group | – | –Participants with complicated monochorionic pregnancies (MC) will be followed prospectively beginning at the time of the mother's evaluation for a complication related to monochorionic (MC) multiple pregnancies through delivery of the child and follow-up of the child to 12 months of life. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of Monochorionic pregnancies (maternal, fetal, and neonatal data) that have undergone evaluation and/or treatment for complications attributable to monochorionic twin pregnancy at the University of Miami.
Key inclusion criteria (2 listed)
- The study population will consist of MC pregnancies (maternal, fetal, and neonatal data) that have undergone evaluation and/or treatment for complications attributable to monochorionic twin pregnancy at the University of Miami.
- Maternal age 18 years and older.
Key exclusion criteria (2 listed)
- Participation declined or consent not granted in prospective arm
- Loss to follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with Preterm Delivery
Time frame: Up to 42 weeks gestation
Preterm delivery is defined as birth <37 weeks gestation
Number of participant with Premature Spontaneous Rupture of the Membranes
Time frame: Up to 42 weeks
As per clinical evaluation
Number of Infant Deaths
Time frame: Up to 12 months post infant delivery
The Number of Infant Deaths
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
Related trials for Monochorionic Diamniotic Placenta
Active, not recruitingObservational study
Is the Vaginal Microbiome and Metabolome Associated With Spontaneous Preterm Birth (sPTB) in Multiple Pregnancies?
Preterm Birth, Preterm Labor
Not yet recruiting
MoDi Twin Placental Imaging
Monochorionic Diamniotic Placenta, Monochorial Monoamniotic Placenta
RecruitingObservational study
Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China
Twin Pregnancy, Antepartum Condition or Complication, Twin to Twin Transfusion as Antepartum Condition
RecruitingObservational study
Laser Photocoagulation of Communicating Vessels in Twin-to-Twin Transfusion Syndrome
Twin to Twin Transfusion as Antepartum Condition, Monochorionic Diamniotic Placenta
RecruitingObservational study
Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation
Twin; Pregnancy, Affecting Fetus or Newborn, Fetal Growth Retardation
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.
Rodrigo Ruano, MD PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monochorionic Diamniotic Placenta and Monochorial Monoamniotic Placenta, run by University of Miami 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 2 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants with Preterm Delivery (time frame: Up to 42 weeks gestation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2026.