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

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: Active, not recruiting
• Conditions: Twin to Twin Transfusion Syndrome

• Study Type: Observational
• Enrollment (Actual): 179

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Hopital Robert Debre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

How is the study designed?

Number of groups / cohorts

1

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	measure of the arterial blood pressure; cardiac echography	one day
Composite measure of the renal function	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	provoked oral hyperglycemia; level of glycemia; level of insulinemia; level of glycosuria	one day

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Société Française d'Hypentension Artérielle
• Investigators: Principal Investigator: Laurence Bussières, Ph.D, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 3, 2007
• Primary Completion (ANTICIPATED): June 30, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: July 2, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (ESTIMATE): November 23, 2015

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 5, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: twin to twin,; transfusion syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Hematologic Diseases; Infant, Newborn, Diseases; Anemia; Anemia, Neonatal; Syndrome; Fetofetal Transfusion
• Other Study ID Numbers: CRC05069