Progesterone in Threatened Abortion
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ClinicalTrials.gov Identifier: NCT02950935 |
Recruitment Status :
Terminated
(Difficulty in recruitment)
First Posted : November 1, 2016
Last Update Posted : July 20, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Threatened Abortion in First Trimester | Drug: Progesterone Drug: Placebo | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Progesterone
25 mg of subcutaneous progesterone will be administered twice à day until the 12th week of gestation.
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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.
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Drug: Placebo
subcutaneous injection of placebo solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy. |
- Ongoing pregnancy rate at 12 weeks of gestation [ Time Frame: 12 weeks ]
- Reduction of the frequency of uterine contractions; [ Time Frame: 15 days ]
- Pain reduction (using a Numerical Rating Scale); [ Time Frame: 15 days ]
- Reduction of subchorionic haematoma; [ Time Frame: 15 days ]Size of subchorionic haematoma will be measured (in mm) at screening and after treatment.
- 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 |
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.

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
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 |
Responsible Party: | IBSA Institut Biochimique SA |
ClinicalTrials.gov Identifier: | NCT02950935 |
Other Study ID Numbers: |
16I-Prg06 |
First Posted: | November 1, 2016 Key Record Dates |
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 |
Abortion, Threatened Pregnancy Complications Progesterone Progestins |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |