Tvillinger Til Tiden: Kan progesteron forebygge meget tidlig fødsel hos tvillingegravide?

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2006
INTERVENTION: Pharmaceutical Form: Vaginal capsule, soft INN or Proposed INN: Natural micronized progesterone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Pharmaceutical form of the placebo: Vaginal capsule, soft Route of administration of the placebo: Vaginal use CONDITION: Prevention of preterm labour PRIMARY OUTCOME: Main Objective: To assess the effectiveness of progesterone in the prevention of preterm delivery in twin pregnancies Primary end point(s): The primary end point is the incidence of delivery < 34 weeks, in the study group versus the control group. Secondary Objective: 1) Physical and neurological development of the children at 6 and 18 months; 2) The relationship between cervical length and prophylactic progesterone treatment; 3) Determination of proteomics and RNA in preterm delivery and term delivery and an evaluation of the effect of progesterone on proteomics and RNA; 4) Assessment of the potential anti‐inflammatory effect of progesterone by cytokine‐measurements; 5) Assessment of the effect of progesterone on CRH‐levels in twin pregnancies; INCLUSION CRITERIA: 1) Twin pregnancy 2) Informed consent 3) 18‐23 weeks’ gestation 4) Participants must be able to speak and understand the language spoken in the respective centres Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 90847a379c77caf15e45ab46726ebd55eb362984
First added on: Aug 21, 2024