Non-interventional Study of Therapy for Threatened Miscarriage

NCT03309735 | Completed

• 1 other identifier: 0717-1
• Study Type: observational
• Target: 1,241
• Locations: 1 country
• Sites: 17

Brief 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)

Conditions

Threatened Miscarriage

Keywords

threatened miscarriage; miscarriage; micronized progesterone; dydrogesterone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Speed of arrest of acute symptoms of threatened miscarriage

  Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)

• Duration of hospitalization

  Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)

• Severity of patient's condition

  Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)

• Psycho-emotional status of patients

  Through study completion (until the date of patient discharge from hospital, an averade 7-14 days)

Other Outcomes (1)

• Evaluation of AE/SAE

  From the moment of signing of informed consent through study completion (until the date of patient discharge from hospital, an averade 7-14 days)

Study Arms (3)

1

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

Drug: Micronized progesterone

2

Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed

Drug: Micronized progesterone

3

Duphaston, orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear

Drug: Dydrogesterone

Interventions

Micronized progesterone DRUG

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

Also known as: Utrogestan

1

Dydrogesterone DRUG

Duphaston, orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear

Also known as: Duphaston

3

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 18-35 years with a confirmed threat of miscarriage with a gestation period of 8 to 22 full weeks.

You may qualify if:

• Signed informed consent of the patient to participate in the study;
• Women aged 18-35 years;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Besins Healthcare: lead
• Clinical Research Laboratory, CRO, Russia: collaborator

Study Sites (17)

City Clinical Hospital of the Demsk District

Ufa, Bashkortostan Republic, 450000, Russia

Location

Maternity hospital №1

Krasnoyarsk, Krasnoyarsk Region, 660000, Russia

Location

Regional perinatal center

Kursk, Kursk Oblast, 305000, Russia

Location

Chekhov district hospital №1

Chekhov, Moscow Oblast, 142300, Russia

Location

Central district hospital

Zhukovsky, Moscow Oblast, 140180, Russia

Location

Center for Family Planning and Reproduction

Novosibirsk, Novosibirsk Oblast, 630000, Russia

Location

Maternity hospital №2

Omsk, Omsk Oblast, 644000, Russia

Location

Maternity hospital №6

Omsk, Omsk Oblast, 644000, Russia

Location

Сity hospital №7

Samara, Samara Oblast, 443000, Russia

Location

Stavropol Central District Hospital

Stavropol, Stavropol Kray, 445004, Russia

Location

Сentral city hospital

Kamensk-Uralsky, Sverdlovsk Oblast, 623400, Russia

Location

City Clinical Hospital №16

Kazan', Tatarstan Republic, 420000, Russia

Location

City Clinical Hospital № 8

Voronezh, Voronezh Oblast, 394000, Russia

Location

Regional Perinatal Center

Yaroslavl, Yaroslavl Oblast, 150042, Russia

Location

City Clinical Hospital №68

Moscow, 109263, Russia

Location

Pirogov Russian National Research Medical University (RNRMU)

Moscow, 117997, Russia

Location

Maternity hospital №17

Moscow, 127247, Russia

Location

MeSH Terms

Conditions

Abortion, Threatened; Abortion, Spontaneous

Interventions

Progesterone; Utrogestan; Dydrogesterone

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Pregnadienes

Study Officials

• Igor Manuhin, PhD

  Moscow State University of Medicine and Dentistry named after A.I. Evdokimov

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 16, 2017
• Study Start: October 16, 2017
• Primary Completion: December 22, 2017
• Study Completion: December 22, 2017
• Last Updated: January 18, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (17)