Progesterone in Threatened Abortion

NCT02950935 | Terminated Phase 3

• 1 other identifier: 16I-Prg06
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 4

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.

Conditions

Threatened Abortion in First Trimester

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate at 12 weeks of gestation

  12 weeks

Secondary Outcomes (4)

• Reduction of the frequency of uterine contractions;

  15 days

• Pain reduction (using a Numerical Rating Scale);

  15 days

• Reduction of subchorionic haematoma;

  15 days

• Number of subjects with onset of new threatened abortion

  12 weeks

Study Arms (2)

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

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

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

Study Sites (4)

"F. Miulli" Regional General Hospital

Bari, BA, 70021, Italy

Location

P.O.G. Salesi

Ancona, 60126, Italy

Location

Ospedale Cervesi

Cattolica, Italy

Location

Presidio Ospedale S'Anna

Torino, 10126, Italy

Location

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 1, 2016
• Study Start: April 4, 2017
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2018
• Last Updated: July 20, 2018

Record last verified: 2018-07

Locations

IT (4)