Progesterone in Threatened Abortion

• Status: Terminated
• Trial end date: 2018-05-02
• Target enrollment: 0
• Participant gender: Female

Summary

The main objective of this study will be to assess the efficacy of natural progesterone at a daily dose of 25 mg/bid in the maintenance of early pregnancy in women with symptoms of threatened abortion. The secondary objectives will be the efficacy of progesterone in reducing both pain and uterine contractions.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IBSA Institut Biochimique SA
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Pregnant women attending the emergency room of the study sites with the following characteristics:

• Able and willing to sign the Subject Informed Consent Form and adhere to the study visit schedule;

• Age: 18-37 years;

• BMI: 18-28 kg/m2;

• Symptoms of threatened abortion (vaginal bleeding , with or without pelvic pain);

• Ultrasound proof of viable singleton intrauterine pregnancy (positive foetal heart beat);

• Gestation week ≥6 weeks (5 w +1d) and <12 weeks (11 w + 1d) according to ultrasound dating (CRL);

• Closed uterine cervix;

• At the first case of threatened abortion in the current pregnancy.

Exclusion Criteria:

• Pregnancy obtained via ART treatment;

• Subchorionic haematoma with >50% placental detachment;

• History of recurrent miscarriage;

• Severe uterine malformations;

• Known hypersensitivity to study medication;

• Neoplasias (known or suspected breast or genital tract cancer);

• Severe impairment of hepatic or renal function;

• Use of concomitant medications that might interfere with study evaluations (other hormonal treatment or drugs affecting uterine contractility);

• Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events;

• Porphyria;

• A history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy;

• Antiphospholipid syndrome;

• Diabetes mellitus;

• Known thyroid diseases or autoimmune conditions.