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Progesterone in Threatened Abortion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02950935
Recruitment Status : Terminated (Difficulty in recruitment)
First Posted : November 1, 2016
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA

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

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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

Resource links provided by the National Library of Medicine


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.




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 ]


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02950935


Locations
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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

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

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

Additional relevant MeSH terms:
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Abortion, Threatened
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs