CompletedNot Applicable

Randomized Controlled Trial Comparing a Conservative Management and Laser Surgery

United States179 participantsStarted 2011-04-19

Plain-language summary

The objective of this trial is to compare both strategies (Expectative Vs Fetoscopic laser surgery) for patients with stage 1 TTTS and favorable obstetrical parameters in an international randomized controlled trial. This trial will answer an important question and will help in the management and tailoring of surgical indications in stage 1 TTTS.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * TTTS stage 1 (Euro foetus criteria) * Gestational age \> 16 and \< 26 weeks * Age \> 18 * Informed consent Exclusion Criteria: * Therapeutic amniocentesis prior to referral * Short cervix \< 15 mm on transvaginal US * Severe maternal discomfort:Dyspnea and orthopnea, Abdominal pain \> 4 on a 10-level visual analogic pain scale, Contractions \> 1 per hour * PPROM * Fetal malformations unrelated to TTTS * Follow-up is impossible

What they're measuring

survival and neurological morbidity at the age of 6 months for each foetus randomized

Timeframe: 6 MONTHS

Trial details

NCT IDNCT01220011

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09-30

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