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Progesterone in Threatened Abortion

Primary Purpose

Threatened Abortion in First Trimester

Status
Terminated
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Progesterone
Placebo
Sponsored by
IBSA Institut Biochimique SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Threatened Abortion in First Trimester

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • "F. Miulli" Regional General Hospital
  • P.O.G. Salesi
  • Ospedale Cervesi
  • Presidio Ospedale S'Anna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Progesterone

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Ongoing pregnancy rate at 12 weeks of gestation

Secondary Outcome Measures

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

Full Information

First Posted
October 27, 2016
Last Updated
July 18, 2018
Sponsor
IBSA Institut Biochimique SA
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1. Study Identification

Unique Protocol Identification Number
NCT02950935
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruitment
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
May 2, 2018 (Actual)
Study Completion Date
May 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IBSA Institut Biochimique SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Threatened Abortion in First Trimester

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progesterone
Arm Type
Experimental
Arm Description
25 mg of subcutaneous progesterone will be administered twice à day until the 12th week of gestation.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo will be administered twice à day until the 12th week of gestation.
Intervention Type
Drug
Intervention Name(s)
Progesterone
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
subcutaneous injection of placebo solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.
Primary Outcome Measure Information:
Title
Ongoing pregnancy rate at 12 weeks of gestation
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Reduction of the frequency of uterine contractions;
Time Frame
15 days
Title
Pain reduction (using a Numerical Rating Scale);
Time Frame
15 days
Title
Reduction of subchorionic haematoma;
Description
Size of subchorionic haematoma will be measured (in mm) at screening and after treatment.
Time Frame
15 days
Title
Number of subjects with onset of new threatened abortion
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
"F. Miulli" Regional General Hospital
City
Bari
State/Province
BA
ZIP/Postal Code
70021
Country
Italy
Facility Name
P.O.G. Salesi
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Ospedale Cervesi
City
Cattolica
Country
Italy
Facility Name
Presidio Ospedale S'Anna
City
Torino
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

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Progesterone in Threatened Abortion

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