Twin Pregnancy With Antenatal ProblemNCT05761769
Twin Pregnancy: a Challenge for Patients, Families and Health Professionals
An observational study of Twin Pregnancy With Antenatal Problem and Twin Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Twin pregnancies represent 3-4% of all births and in the last two decades the rate of twin pregnancies has steadily increased, essentially due to the spread of assisted fertilization techniques, the use of drugs that stimulate ovulation and increase in maternal age at conception. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Twin Pregnancy With Antenatal Problem, Twin Diseases, Twin Placenta
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 9 Apr 2021to 1 Dec 2025
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: All women with BC or MC twin pregnancies, who arrive, consecutively, in our Multiple Pregnancy Clinic, at the Obstetrics Day Hospital, regardless of gestational age, will be invited to participate in the project
Who may be able to join
- Maternal age > 18 years
- Twin pregnancy with two or more viable fetuses
- Signature of the informed consent
Who cannot join
- Women without the ability to understand the protocol
- Women for whom the attending physician contraindicates participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Gemelli IRCCS
Rome
Elisa Bevilacqua, +390630155897, elisa.bevilacqua@policlinicogemelli.it
About this study
Twin pregnancies represent 3-4% of all births and in the last two decades the rate of twin pregnancies has steadily increased, essentially due to the spread of assisted fertilization techniques, the use of drugs that stimulate ovulation and increase in maternal age at conception.
Multiple pregnancies pose unique challenges for the patient, families, caregivers and society. Indeed, twin pregnancy is associated with an increased risk compared with singleton pregnancies of all feto-maternal complications of pregnancy (Level of Evidence II-2).
Read more
In twin pregnancies (both monochorionic, MC, and bichorionic, BC) the incidence of preeclampsia is about 10%, 3 times higher than in singleton pregnancies. In singleton pregnancy, the mean gestational age (GE) at delivery is 39 weeks, the mean GA at delivery in twin pregnancies is less than 36 weeks, reflecting a 9-fold higher prevalence of spontaneous preterm delivery than in singleton pregnancy. Gestational diabetes complicates about 22% of twin pregnancies compared to 7-11% of singleton pregnancies. Twin pregnancy, compared to single pregnancy, has an increased incidence of perinatal and neonatal mortality, low birth weight, chromosomal or structural defects.
A key factor to know is chorionicity. Chorionicity is a key data to acquire in the first trimester. Indeed, some complications of twin pregnancy are specific to MC pregnancy. About 20-33% of twins share the same placenta and it is precisely in these cases that a condition of greater risk is created. The most common complications of MC pregnancy are: twin-to-twin transfusion syndrome (TTTS), due to the presence of vascular anastomoses at the level of the placenta and a clear imbalance in blood flow between the twins; selective intrauterine growth restriction; the anemia-polycythemia sequence (TAPS); twin reversed arterial perfusion (TRAPS). Thus, the MC twin pregnancy is at increased risk of feto-maternal complications.
The complications of twin pregnancy place a heavy emotional and economic burden on parents, families and society.
There is no consensus in the literature on what should be the most appropriate methods for surveillance of multiple pregnancy: when to perform laboratory, instrumental and diagnostic tests for follow-up and monitoring of maternal-fetal well-being.
The aim of this project is to create a complete and accurate database that takes into consideration all aspects related to twin pregnancy. The twin pregnancy will be followed by a team of multiple pregnancy specialists who will follow the international guidelines for the surveillance of multiple pregnancy. The aim is to identify the optimal management of multiple pregnancy, collecting, studying and comparing the largest possible number of clinical, laboratory and ultrasound data from the beginning of pregnancy to the postpartum visit, developing clinical-diagnostic care pathways for follow-up and possible prevention of complications, personalized and adapted to each single woman with a twin pregnancy.
The women participating in the study will be able to enjoy close surveillance by a center specialized in the management of multiple pregnancies, this will allow for optimal management of the twin pregnancy with early identification and treatment of any complications identified.
Study typology Prospective observational longitudinal study of the overall management of patients with multiple pregnancies.
- Being tested
- no intervention
- Medical subject headings
- Diseases in Twins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the outcomes between twin pregnancies with and without complications after introducing a specific clinical surveillance protocol that complies with the international guidelines available.
To compare the outcomes between twin pregnancies with and without complications after introducing a specific clinical surveillance protocol that complies with the international guidelines available.
Measured: through study completion, an average of 1 year
Identify the optimal management of multiple pregnancy, identifying markers or combination of biomarkers for the early prevention of complications in multiple pregnancy in the first, second or third trimester
Identify the optimal management of multiple pregnancy, identifying markers or combination of biomarkers for the early prevention of complications in multiple pregnancy in the first, second or third trimester
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start9 Apr 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin Pregnancy With Antenatal ProblemStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa Bevilacqua, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761769
- Sponsor's protocol ID
- 3797
- Status last verified
- Mar 2025
- First submitted
- 13 Feb 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twin Pregnancy: a Challenge for Patients, Families and Health Professionals
- ClinicalTrials.gov ID
- NCT05761769
- Acronym / sponsor ID
- 3797
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 Mar 2023 (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.
Twin pregnancies represent 3-4% of all births and in the last two decades the rate of twin pregnancies has steadily increased, essentially due to the spread of assisted fertilization techniques, the use of drugs that stimulate ovulation and increase in maternal age at conception.
Multiple pregnancies pose unique challenges for the patient, families, caregivers and society. Indeed, twin pregnancy is associated with an increased risk compared with singleton pregnancies of all feto-maternal complications of pregnancy (Level of Evidence II-2).
In twin pregnancies (both monochorionic, MC, and bichorionic, BC) the incidence of preeclampsia is about 10%, 3 times higher than in singleton pregnancies. In singleton pregnancy, the mean gestational age (GE) at delivery is 39 weeks, the mean GA at delivery in twin pregnancies is less than 36 weeks, reflecting a 9-fold higher prevalence of spontaneous preterm delivery than in singleton pregnancy. Gestational diabetes complicates about 22% of twin pregnancies compared to 7-11% of singleton pregnancies. Twin pregnancy, compared to single pregnancy, has an increased incidence of perinatal and neonatal mortality, low birth weight, chromosomal or structural defects.
A key factor to know is chorionicity. Chorionicity is a key data to acquire in the first trimester. Indeed, some complications of twin pregnancy are specific to MC pregnancy. About 20-33% of twins share the same placenta and it is precisely in these cases that a condition of greater risk is created. The most common complications of MC pregnancy are: twin-to-twin transfusion syndrome (TTTS), due to the presence of vascular anastomoses at the level of the placenta and a clear imbalance in blood flow between the twins; selective intrauterine growth restriction; the anemia-polycythemia sequence (TAPS); twin reversed arterial perfusion (TRAPS). Thus, the MC twin pregnancy is at increased risk of feto-maternal complications.
The complications of twin pregnancy place a heavy emotional and economic burden on parents, families and society.
There is no consensus in the literature on what should be the most appropriate methods for surveillance of multiple pregnancy: when to perform laboratory, instrumental and diagnostic tests for follow-up and monitoring of maternal-fetal well-being.
The aim of this project is to create a complete and accurate database that takes into consideration all aspects related to twin pregnancy. The twin pregnancy will be followed by a team of multiple pregnancy specialists who will follow the international guidelines for the surveillance of multiple pregnancy. The aim is to identify the optimal management of multiple pregnancy, collecting, studying and comparing the largest possible number of clinical, laboratory and ultrasound data from the beginning of pregnancy to the postpartum visit, developing clinical-diagnostic care pathways for follow-up and possible prevention of complications, personalized and adapted to each single woman with a twin pregnancy.
The women participating in the study will be able to enjoy close surveillance by a center specialized in the management of multiple pregnancies, this will allow for optimal management of the twin pregnancy with early identification and treatment of any complications identified.
Study typology Prospective observational longitudinal study of the overall management of patients with multiple pregnancies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All women with BC or MC twin pregnancies, who arrive, consecutively, in our Multiple Pregnancy Clinic, at the Obstetrics Day Hospital, regardless of gestational age, will be invited to participate in the project
Key inclusion criteria (3 listed)
- Maternal age > 18 years
- Twin pregnancy with two or more viable fetuses
- Signature of the informed consent
Key exclusion criteria (2 listed)
- Women without the ability to understand the protocol
- Women for whom the attending physician contraindicates participation in the study
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
To compare the outcomes between twin pregnancies with and without complications after introducing a specific clinical surveillance protocol that complies with the international guidelines available.
Time frame: through study completion, an average of 1 year
To compare the outcomes between twin pregnancies with and without complications after introducing a specific clinical surveillance protocol that complies with the international guidelines available.
Identify the optimal management of multiple pregnancy, identifying markers or combination of biomarkers for the early prevention of complications in multiple pregnancy in the first, second or third trimester
Time frame: through study completion, an average of 1 year
Identify the optimal management of multiple pregnancy, identifying markers or combination of biomarkers for the early prevention of complications in multiple pregnancy in the first, second or third trimester
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 11 Mar 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Twin Pregnancy With Antenatal Problem
Active, not recruitingObservational study
Twin Pregnancy Cohort
Pregnant With Complication, Twin Pregnancy With Antenatal Problem
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.
Elisa Bevilacqua principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Twin Pregnancy With Antenatal Problem and Twin Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 3 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: looking for participants now, as of the sponsor's last update on 11 Mar 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 Italy. 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?
Contact Elisa Bevilacqua (+390630155897, elisa.bevilacqua@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the outcomes between twin pregnancies with and without complications after introducing a specific clinical surveillance protocol that complies with the international guidelines available. (time frame: through study completion, an average of 1 year). The study lists 2 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 11 Mar 2025.