Clinical trial NCT02950935: Progesterone in Threatened Abortion
Official title: Prospective, Double-blind, Randomised, Placebo Controlled, Phase III Clinical Study Assessing the Efficacy of Natural Progesterone 25 mg/Bid Administered Subcutaneously in the Maintenance of Early Pregnancy in Women With Symptoms of Threatened Abortion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Threatened Abortion in First Trimester
Lead sponsor: IBSA Institut Biochimique SA
Sponsor class: INDUSTRY
First posted: 2016-11-01
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Ongoing pregnancy rate at 12 weeks of gestation
timeFrame: 12 weeks
Secondary outcomes:
measure: Reduction of the frequency of uterine contractions;
timeFrame: 15 days
measure: Pain reduction (using a Numerical Rating Scale);
timeFrame: 15 days
measure: Reduction of subchorionic haematoma;
timeFrame: 15 days
measure: Number of subjects with onset of new threatened abortion
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bari
country: Italy
facility: "F. Miulli" Regional General Hospital
state: BA
city: Ancona
country: Italy
facility: P.O.G. Salesi
city: Cattolica
country: Italy
facility: Ospedale Cervesi
city: Torino
country: Italy
facility: Presidio Ospedale S'Anna
Study officials:
References: