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

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.

Study Overview

• Status: Terminated
• Conditions: Threatened Abortion in First Trimester
• Intervention / Treatment: Drug: Progesterone; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Ancona, Italy, 60126
    • P.O.G. Salesi
  • Cattolica, Italy
    • Ospedale Cervesi
  • Torino, Italy, 10126
    • Presidio Ospedale S'Anna
  • BA
    • Bari, BA, Italy, 70021
      • "F. Miulli" Regional General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 37 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Progesterone; 25 mg of subcutaneous progesterone will be administered twice à day until the 12th week of gestation.	Drug: Progesterone; subcutaneous injection of progesterone solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.
PLACEBO_COMPARATOR: Placebo; placebo will be administered twice à day until the 12th week of gestation.	Drug: Placebo; subcutaneous injection of placebo solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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;	Size of subchorionic haematoma will be measured (in mm) at screening and after treatment.	15 days
Number of subjects with onset of new threatened abortion		12 weeks

Collaborators and Investigators

• Sponsor: IBSA Institut Biochimique SA

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 4, 2017
• Primary Completion (ACTUAL): May 2, 2018
• Study Completion (ACTUAL): May 2, 2018

Study Registration Dates

• First Submitted: October 27, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (ESTIMATE): November 1, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Threatened; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: 16I-Prg06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No