Progesterone in Threatened Abortion

NCT ID: NCT02950935

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-04
• Study Completion Date: 2018-05-02

Brief 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.

Conditions

Threatened Abortion in First Trimester

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Progesterone

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

Group Type: EXPERIMENTAL

Progesterone

Intervention Type: DRUG

subcutaneous injection of progesterone solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

subcutaneous injection of placebo solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.

Interventions

Progesterone

subcutaneous injection of progesterone solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.

Intervention Type: DRUG

Placebo

subcutaneous injection of placebo solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IBSA Institut Biochimique SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

"F. Miulli" Regional General Hospital

Bari, BA, Italy

P.O.G. Salesi

Ancona, , Italy

Ospedale Cervesi

Cattolica, , Italy

Presidio Ospedale S'Anna

Torino, , Italy

Countries

Italy

Other Identifiers

16I-Prg06

Identifier Type: -

Identifier Source: org_study_id