Progesterone in Threatened Abortion

Phase 3

Terminated

• Conditions: Threatened Abortion in First Trimester
• Interventions: Drug: Placebo; Drug: Progesterone

• Registration Number: NCT02950935
• Lead Sponsor: IBSA Institut Biochimique SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-27
• Study First Submitted QC: 2016-10-31
• Study First Posted: 2016-11-01
• Study Start: 2017-04-04
• Primary Completion: 2018-05-02
• Study Completion: 2018-05-02
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-18
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo will be administered twice à day until the 12th week of gestation.
Progesterone	Progesterone	25 mg of subcutaneous progesterone will be administered twice à day until the 12th week of gestation.

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate at 12 weeks of gestation	12 weeks

Secondary Outcome Measures

Name	Time	Method
Reduction of the frequency of uterine contractions;	15 days
Pain reduction (using a Numerical Rating Scale);	15 days
Reduction of subchorionic haematoma;	15 days	Size of subchorionic haematoma will be measured (in mm) at screening and after treatment.
Number of subjects with onset of new threatened abortion	12 weeks

Trial Locations

Locations (4)

P.O.G. Salesi; 🇮🇹 Ancona, Italy

Presidio Ospedale S'Anna; 🇮🇹 Torino, Italy

"F. Miulli" Regional General Hospital; 🇮🇹 Bari, BA, Italy

Ospedale Cervesi; 🇮🇹 Cattolica, Italy