Progesterone in Threatened Abortion | NCT02950935

Studies
Progesterone in Threatened Abortion

NCT02950935

Sponsor

IBSA Institut Biochimique SA

Status

Terminated

Last Update Posted

Jul 20, 2018Actual

Enrollment

4Actual

Phase

Phase 3

Conditions

Threatened Abortion in First Trimester

Interventions

Progesterone
Placebo

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty in recruitment

Expanded Access Info

Start Date

Apr 4, 2017Actual

Primary Completion Date

May 2, 2018Actual

Completion Date

May 2, 2018Actual

First Submitted Date

Oct 27, 2016

First Submission Date that Met QC Criteria

Oct 31, 2016

First Posted Date

Nov 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2018

Last Update Posted Date

Jul 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Progesterone	Experimental	25 mg of subcutaneous progesterone will be administered twice à day until the 12th week of gestation.	Drug: Progesterone
Placebo	Placebo Comparator	placebo will be administered twice à day until the 12th week of gestation.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Progesterone	Drug	subcutaneous injection of progesterone solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.	Progesterone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ongoing pregnancy rate at 12 weeks of gestation		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Reduction of the frequency of uterine contractions;		15 days
Pain reduction (using a Numerical Rating Scale);		15 days
Reduction of subchorionic haematoma;

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

37 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
"F. Miulli" Regional General Hospital		Bari	BA	70021	Italy
P.O.G. Salesi

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473