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Completed

NCT Number: NCT02611856

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

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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Robert Debré

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Composite measure of the cardiac function

    Time frame: one day

    • measure of the arterial blood pressure
    • cardiac echography
  2. Composite measure of the renal function

    Time frame: one day

    • microalbuminuria
    • level of plasmatic renin, plasmatic cortisol, prorenin, aldosterone
    • renal echography

Secondary outcomes

  1. Composite measure of the glycoregulation

    Time frame: one day

    • provoked oral hyperglycemia
    • level of glycemia
    • level of insulinemia
    • level of glycosuria

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

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

Registry information

Official study title

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

Acronym: STT

Important dates

Study start
2007
Primary completion
2022
Study completion
2022
First posted
Nov 23, 2015
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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