Monochorial-diamniotic Pregnancies Complicated With a Twin-to-twin Syndrome (STT)

March 23, 2026 updated by: Assistance Publique - Hôpitaux de Paris

STT Study : Pediatric Follow-up of Children's From Monochorial-diamniotic Pregnancies Complicated With a Twin-to-twin Syndrome

The twin pregnancies monochorionic are specifically explained to two main types of complications: the anomalies of the embryo affecting a symmetry and in particular the median line on one hand and malformative sequences of vascular origin on the other hand. This last category of anomalies (twin-to-twin syndrome, TTTS) develops because of the presence of a division of the foeto-placentary circulation between both twins through the pooling of certain placentary cotyledons. The latter are then vascularized by an arterial and venous foot belonging to both foetuses (anastomoses arteria-venous or veinous-arterial). It results from it an imbalance moderate but very early hemodynamic which is going to return a hypovolume twin (the donor) and its plethoric co-twin (the recipient).

These anomalies in utero could not only have consequences during the fetal life, on the born weight and the later development of newborns, but also on the organization and the functioning of a whole series of physiological systems. So these anomalies of the pregnancy could have also consequences which exceed by very far from the perinatal period, by favoring the development of the atheroma, the high blood pressure, the resistance in the insulin, and many other metabolic and endocrine functions were known for their importance in human pathology.

For these reasons the investigators suggest estimating the tensional, cardiac and metabolic status of children ex-transfusers and of children ex-transfused in 2 different age classes: between 4 and 8 years then when these children will have between 12 and 16 years.

There are also some evaluation clinical and biological of the puberty (only at the age of 12-16)

To understand a possible effect of the prenatal status of these children on the endocrinology of the puberty, the measures and the following dosages will be realized:

  • Test in the GnRH (T0, T30, T60, T90): dosages of LH and FSH (relationship of peaks to determine the puberty evolution),
  • Dosages of the sexual steroids, the oestradiol for the girl and the testosterone for the boy,
  • Clinical examination looking for the signs of puberty

This if study leans on the big originality of the physiopathological model of TTTS in which the children present the peculiarity to have an identical genetic and postnatal status and a different prenatal environment.

The follow-up of these children should allow:

  • To understand better the postnatal impact anomalies on these children in the course of pregnancy
  • To anticipate and thus to improve their care in case of appearance of biological or clinical signs

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

179

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Hôpital Robert Debré

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 8 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children aged 4 years to 8 years

Description

Inclusion Criteria:

  • Child (ren) from (s) of a twin pregnancy with fetal transfusion syndrome fetal
  • Child (ren) age (s) 4 years 0 months to 6 years 12 months
  • Child (ren) fasting
  • Consent signed by the parents or legal representative

Exclusion Criteria:

  • Child (ren) not derived (s) of a twin pregnancy with fetal transfusion syndrome fetal
  • Child (ren) age (s) under 4 years 0 months or more than 6 years 12 months
  • Child (ren) nonfasting

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
monochorial-biamniotic pregnancies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite measure of the cardiac function
Time Frame: one day
  • measure of the arterial blood pressure
  • cardiac echography
one day
Composite measure of the renal function
Time Frame: one day
  • microalbuminuria
  • level of plasmatic renin, plasmatic cortisol, prorenin, aldosterone
  • renal echography
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite measure of the glycoregulation
Time Frame: one day
  • provoked oral hyperglycemia
  • level of glycemia
  • level of insulinemia
  • level of glycosuria
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin
Société Française d'Hypentension Artérielle

Investigators

  • Principal Investigator: Yves Ville, PU-PH, Assistance Publique - Hopitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2007

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

July 2, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimated)

November 23, 2015

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P050314
  • CRC05069 (Other Identifier: CRC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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