Non-interventional Study of Therapy for Threatened Miscarriage

Threatened Miscarriage Clinical Trial

Official title:

Multicenter Open Prospective Comparative Non-interventional Study of Therapy for Threatened Miscarriage With Medicinal Products Utrogestan, 200 mg Capsules (Besins Healthcare SA, Belgium), and Duphaston, 10 mg Coated Tablets (Abbott Healthcare Products B.V., the Netherlands)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03309735
• Other study ID #: 0717-1
• Status: Completed
• Phase: N/A
• First received: October 5, 2017
• Last updated: January 17, 2018
• Start date: October 16, 2017
• Est. completion date: December 22, 2017

Study information

• Verified date: January 2018
• Source: Besins Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Study the efficacy and safety of therapy for threatened miscarriage with medicinal products Utrogestan (micronized progesterone), 200 mg capsules (Besins Healthcare SA, Belgium), and Duphaston (Dydrogesterone), 10 mg coated tablets (Abbott Healthcare Products B.V., the Netherlands)

Description:

Open comparative non-interventional study.

During the study three visits are planned:

Visit 1 (enrollment) is conducted when the patient is hospitalized in a hospital (providing medical care to pregnant women diagnosed with threatened miscarriage) due to the threat of miscarriage when the inclusion/exclusion criteria are met (women aged 18-35 years with a confirmed threat of miscarriage with a gestation period of 8 to 22 full weeks). Depending on the chosen therapy tactics (this therapy is routine in Russia), all patients are allocated to one of the three study groups:

Group I receives Utrogestan (micronized progesterone), 200 mg orally thrice a day until acute symptoms of the threat of termination of pregnancy (scarlet discharge from the genital tract, pain in the abdomen) and then Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed; Group II receives Utrogestan (micronized progesterone) vaginally 200 mg twice a day and 200 mg orally once a day before bed; Group III receives Duphaston (Dydrogesterone), orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear.

Visit 2 (on the third day of the study/hospitalization). If pregnancy is interrupted earlier, Visit 3 is made.

Visit 3 (on the day of discharge from the hospital: with prolonged or interrupted pregnancy)

Routine clinical procedures (accepted in Russia) will be performed during the study:

• Collection of demographic and anthropometric data (age, height, body weight);

• Collection of complaints, medical and obstetric-gynecological history;

• Measurement of blood pressure, heart rate, respiratory rate and body temperature;

• Gynecological examination with the help of gynecological specula;

• Vaginal bimanual examination;

• Transvaginal ultrasound, determination of viability of uterine pregnancy (determination of embryo/fetal heartbeat);

• Assessment of the severity of the patient's condition according to Clinical Global Impression scale;

• Evaluation of psycho-emotional status dynamically using Zigmond-Snaith Hospital Anxiety and Depression Scale;

Efficacy will be evaluated using primary and secondary efficacy endpoints.

Primary efficacy endpoint:

• Discharge from the hospital with prolonged pregnancy;

Secondary efficacy endpoint:

• Speed of arrest of symptoms of threatened miscarriage (blood discharge from the genital tract and drawing pains in the lower abdomen);

• Duration of hospitalization;

• Severity of patient's condition dynamically in the course of therapy;

• Psycho-emotional status of women dynamically in the course of therapy;

Criteria for safety evaluation:

• Evaluation of AE/SAE. All adverse events (As) and serious adverse events (SAE) will be recorded, starting from the moment of signing of informed consent before the end of participation in the study (before discharge from the hospital).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1241
• Est. completion date: December 22, 2017
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Signed informed consent of the patient to participate in the study;

• Women aged 18-35 years;

• Progressive uterine pregnancy at the time of inclusion in the study from 8 to 22 full weeks;

• Drawing pains in the lower abdomen, lumbar region;

• Scanty blood discharge from the genital tract;

• Palpitation of the fetus revealed by ultrasound;

• Prescription by attending physician of Utrogestan or Duphaston, depending on chosen treatment tactics.

A physician should decide on the therapy, as well as tactics of further management of pregnancy before the patient is enrolled in the study and regardless of it.

Exclusion Criteria:

• Stimulated ovulation, use of assisted reproductive technologies;

• Abnormalities in the structure of the uterus;

• Amputation of the cervix;

• Uterine myoma with submucosal location of the node (a clinically significant size);

• Karyotype anomalies of parents (if applicable);

• Aneuploidy, anembrion, fetal malformations, as established causes of loss of previous pregnancies;

• Congenital thrombophilia: factor V gene mutation (Leiden mutation), mutation of the prothrombin gene (if applicable);

• Non-developing pregnancy;

• Other clinically significant causes of miscarriage identified during examination (including but not limited to): pre-pregnancy diabetes, pre-pregnancy uncompensated thyroid dysfunction, history of malignant tumors or current tumors, psychiatric illnesses;

• STDs at the time of inclusion in the study;

• Administration of enzyme-inducing medicinal products (anticonvulsants, antipsychotics, antidepressants, tranquilizers), use of psychoactive substances before and during pregnancy;

• Multiple pregnancy;

• Patients previously included in this study, but who withdrew from the study for any reason;

• Contraindications to therapy with Utrogestan and Duphaston, listed in approved prescribing instructions;

• Contraindications to pregnancy prolongation;

• Any other clinical conditions that, as seen by investigator, contradict inclusion criteria, may lead to the early termination of the patient's participation in the study or make it difficult to interpret the results of the latter;

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Abortion, Threatened
• Threatened Miscarriage

Intervention

Drug:
• Micronized progesterone
Utrogestan, 200 mg orally thrice a day until acute symptoms of the threat of termination of pregnancy (scarlet discharge from the genital tract, pain in the abdomen) and then Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed
• Micronized progesterone
Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed
• Dydrogesterone
Duphaston, orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear

Locations

Country	Name	City	State
Russian Federation	Chekhov district hospital ?1	Chekhov	Moscow Region
Russian Federation	?entral city hospital	Kamensk-Uralsky	Sverdlovsk Region
Russian Federation	City Clinical Hospital ?16	Kazan	Republic Of Tatarstan
Russian Federation	Maternity hospital ?1	Krasnoyarsk	Krasnoyarsk Region
Russian Federation	Regional perinatal center	Kursk	Kursk Region
Russian Federation	City Clinical Hospital ?68	Moscow
Russian Federation	Maternity hospital ?17	Moscow
Russian Federation	Pirogov Russian National Research Medical University (RNRMU)	Moscow
Russian Federation	Center for Family Planning and Reproduction	Novosibirsk	Novosibirsk Region
Russian Federation	Maternity hospital ?2	Omsk	Omsk Region
Russian Federation	Maternity hospital ?6	Omsk	Omsk Region
Russian Federation	?ity hospital ?7	Samara	Samara Region
Russian Federation	Stavropol Central District Hospital	Stavropol	Stavropol Region
Russian Federation	City Clinical Hospital of the Demsk District	Ufa	Bashkortostan Republic
Russian Federation	City Clinical Hospital ? 8	Voronezh	Voronezh Region
Russian Federation	Regional Perinatal Center	Yaroslavl	Yaroslavl Region
Russian Federation	Central district hospital	Zhukovsky	Moscow Region

Sponsors (2)

Lead Sponsor	Collaborator
Besins Healthcare	Clinical Research Laboratory, CRO, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of AE/SAE	All adverse events (AE) and serious adverse events (SAE) will be recorded during the study	From the moment of signing of informed consent through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
Primary	Prolongation of pregnancy	Discharge from the hospital with prolonged pregnancy	Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
Secondary	Speed of arrest of acute symptoms of threatened miscarriage	Speed of arrest of symptoms of threatened miscarriage (blood discharge from the genital tract and drawing pains in the lower abdomen)	Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
Secondary	Duration of hospitalization	Duration of hospitalization	Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
Secondary	Severity of patient's condition	Severity of patient's condition dynamically in the course of therapy	Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)
Secondary	Psycho-emotional status of patients	Psycho-emotional status of women dynamically in the course of therapy	Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)