Progesterone in Threatened Abortion

IBSA

Status and phase: Terminated; Phase 3

Conditions: Threatened Abortion in First Trimester

Treatments: Drug: Placebo; Drug: Progesterone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02950935

16I-Prg06

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4 participants in 2 patient groups, including a placebo group

Progesterone

Experimental group

Description:

25 mg of subcutaneous progesterone will be administered twice à day until the 12th week of gestation.

Treatment:

Drug: Progesterone

Placebo

Placebo Comparator group

Description:

placebo will be administered twice à day until the 12th week of gestation.

Treatment:

Drug: Placebo