RecruitingNCT05761769

Twin Pregnancy: a Challenge for Patients, Families and Health Professionals


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

200 participants

Start Date

Apr 9, 2021

Study Type

OBSERVATIONAL

Conditions

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. 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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This observational study is exploring the psychological, emotional, and practical experiences of women carrying twin pregnancies — and the healthcare professionals who care for them. Twin pregnancies carry significantly higher risks than singleton pregnancies, including premature birth, growth restriction, and maternal complications like gestational diabetes and preeclampsia. Despite these challenges, the lived experience of patients and the clinical decision-making burden on healthcare providers in twin pregnancies is not well characterized, which can leave gaps in support and counseling. To be eligible, you must be a woman over 18 years old with a twin pregnancy where both fetuses are alive, and you must be willing to sign an informed consent form. Women who are unable to understand the study protocol or for whom their physician advises against participation are excluded. Healthcare professionals caring for twin pregnancies are also invited to participate. Participants will complete questionnaires and possibly interviews about their experiences during pregnancy. There is no experimental treatment or intervention — this is purely observational research designed to capture the perspectives of patients and providers. The findings will inform the development of better support structures, patient education materials, and clinical guidelines for managing the unique challenges of twin pregnancy, ultimately improving care and reducing anxiety for families navigating what can be a complicated and emotionally intense journey.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERno intervention

no intervention


Locations(1)

Fondazione Policlinico Universitario Gemelli IRCCS

Rome, Italy

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NCT05761769


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