Progesterone in Threatened Abortion

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02950935

Enrollment

Registered

2016-11-01

Start date

2017-04-04

Completion date

2018-05-02

Last updated

2018-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Threatened Abortion in First Trimester

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.

Interventions

DRUGProgesterone

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 37 Years

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.

Design outcomes

Primary

Measure	Time frame
Ongoing pregnancy rate at 12 weeks of gestation	12 weeks

Secondary

Measure	Time frame	Description
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	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026