Progesterone in Threatened Abortion

Threatened Abortion in First Trimester Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02950935
• Other study ID #: 16I-Prg06
• Status: Terminated
• Phase: Phase 3
• Start date: April 4, 2017
• Est. completion date: May 2, 2018

Study information

• Verified date: July 2018
• Source: IBSA Institut Biochimique SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: May 2, 2018
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Threatened
• Threatened Abortion in First Trimester

Intervention

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

Locations

Country	Name	City	State
Italy	P.O.G. Salesi	Ancona
Italy	"F. Miulli" Regional General Hospital	Bari	BA
Italy	Ospedale Cervesi	Cattolica
Italy	Presidio Ospedale S'Anna	Torino

Sponsors (1)

Lead Sponsor	Collaborator
IBSA Institut Biochimique SA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate at 12 weeks of gestation		12 weeks
Secondary	Reduction of the frequency of uterine contractions;		15 days
Secondary	Pain reduction (using a Numerical Rating Scale);		15 days
Secondary	Reduction of subchorionic haematoma;	Size of subchorionic haematoma will be measured (in mm) at screening and after treatment.	15 days
Secondary	Number of subjects with onset of new threatened abortion		12 weeks