Progesterone in Threatened Abortion

• ClinicalTrials.gov Identifier: NCT02950935
• Recruitment Status: Terminated
• First Posted: November 1, 2016
• Last Update Posted: July 20, 2018
• Sponsor: IBSA Institut Biochimique SA
• Information provided by (Responsible Party): IBSA Institut Biochimique SA

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.

Condition or disease	Intervention/treatment	Phase
Threatened Abortion in First Trimester	Drug: Progesterone; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 4, 2017
• Actual Primary Completion Date: May 2, 2018
• Actual Study Completion Date: May 2, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Ongoing pregnancy rate at 12 weeks of gestation [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Reduction of the frequency of uterine contractions; [ Time Frame: 15 days ]
2. Pain reduction (using a Numerical Rating Scale); [ Time Frame: 15 days ]
3. Reduction of subchorionic haematoma; [ Time Frame: 15 days ]
   Size of subchorionic haematoma will be measured (in mm) at screening and after treatment.
4. Number of subjects with onset of new threatened abortion [ Time Frame: 12 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 37 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Italy

"F. Miulli" Regional General Hospital

Bari, BA, Italy, 70021

P.O.G. Salesi

Ancona, Italy, 60126

Ospedale Cervesi

Cattolica, Italy

Presidio Ospedale S'Anna

Torino, Italy, 10126

Sponsors and Collaborators

IBSA Institut Biochimique SA

More Information

• Responsible Party: IBSA Institut Biochimique SA
• ClinicalTrials.gov Identifier: NCT02950935
• Other Study ID Numbers: 16I-Prg06
• First Posted: November 1, 2016
• Last Update Posted: July 20, 2018
• Last Verified: July 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Abortion, Threatened; Pregnancy Complications; Progesterone; Progestins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs