An Open-Label, Randomized Controlled Trial to Compare the Efficacy and Safety of Oral Dydrogesterone Versus Oral Micronized Progesterone in Treating Threatened Miscarriage and in Modulation of Immune Factors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 304
- 试验地点
- 8
- 主要终点
- Miscarriage rate before 20 weeks of gestation
研究概览
简要总结
This is an Open-Label, Randomized Controlled Trial to Compare the Efficacy and Safety of Oral Dydrogesterone Versus Oral Micronized Progesterone in Treating Threatened Miscarriage and in Modulation of Immune Factors. The primary objective is to compare the reduction in miscarriage rate before 20 weeks of gestation between pregnant women with threatened miscarriage treated with oral dydrogesterone versus oral micronized progesterone.
Subjects satisfying all eligibility criteria will be offered intervention according to randomization till 14 weeks of gestation. The interventional medicinal products will be – Progesterone Micronized oral 200 mg two times a day (BID) or Dydrogesterone 40 mg STAT followed by 10 mg three times a day (TID) for up to 1 week after the bleeding is stopped, or till a maximum of 14 weeks of gestation, or until miscarriage is confirmed within 14 weeks of gestation. The continuation of treatment after 14 weeks of gestation will solely be at the discretion of the treating doctor. All adverse events will be recorded. Data collected at baseline and follow-up visits will be analyzed.
The study visit will be as per the following schedule:
Visit1 (screening and randomization): 5-12 weeks of gestation
Visit 2 (one week after Visit 1): 6-13 weeks of gestation*
Visit 3(two weeks after Visit 2): 8-14 weeks of gestation**
Visit4 (End of treatment visit): 14 weeks (window period: +3 days)
Visit5 (FU visit 1): 18-20 weeks
Visit6 (FU visit 2): 24-26 weeks***
Visit7 (FU visit 3): Telephonic visit post-delivery
*If Visit 2 happens at 13 weeks of gestation, then Visit 3 will be scheduled after 1 week of the same (i.e., at the 14th week)
**If Visit 3 happens before 14 weeks of gestation, the additional visits will be scheduled every 2 weeks until 14 weeks of gestation
➢ Scheduled blood/urine evaluations, and Ultrasonography:
•Visit 1 [CBC, LFT, KFT, Urine routine and culture, HVS culture sensitivity, Blood group, Rh factor, viral markers, immunomodulation markers i.e., serum levels of cytokines (IL-4, IL-10, IFN-γ, and TNF-α), dating USG/Level-1]
•Visit 2 [USG/Level-1]
•Visit 3 [USG/Level-1 or NT-NB scan#, dual marker test]
•Visit 4 [CBC, LFT, KFT, immunomodulation markers, i.e., serum levels of cytokines (IL-4, IL-10, IFN-γ, and TNF-α)]
•Visit 5 [USG/Level 2 scan]
•Visit 6 [CBC, LFT, KFT]
•Visit 7 [Telephonic visit post-delivery]
#NT-NB scan will be done at 11-13 weeks of gestation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 39.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant women aged 20 to 39 years with threatened miscarriage (vaginal bleeding and or abdominal pain)in the first trimester
- •Gestational age between 5 to 12 weeks
- •Euthyroidism or controlled hypothyroidism(based on medical history)
- •Presence of a viable pregnancy
- •Presence of intrauterine gestational sac on ultrasonography if a urine pregnancy test is first positive within the past 2 weeks
- •BMI between 18 and 30 kg per m2
- •Willingness to provide written informed consent.
排除标准
- •Pregnant women with inevitable abortion
- •History of recurrent miscarriage defined as at least two consecutive spontaneous miscarriages
- •Heavy vaginal bleeding or severe abdominal pain requiring surgical intervention
- •Presence of intrauterine fetus with a crown-rump length inappropriate for gestational age, with no visible heartbeat, or a mean gestational sac of greater than equal to 25mm with no viable fetal pole in ultrasound
- •Evidence of ectopic pregnancy
- •Conceived on gonadotrophins or with the use of assisted reproductive technologies
- •Abnormalities in the structure of the uterus or amputation of the cervix, or any other genital tract anomalies
- •Anembrion or fetal malformations as established causes of loss of previous pregnancies
- •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, or psychiatric illnesses)
- •Known Sexually Transmitted Diseases (STDs)
- •Administration of enzyme-inducing medicinal products such as (anticonvulsants, antipsychotics, antidepressants, tranquilizers), use of psychoactive substances before and during pregnancy
- •Multiple pregnancy
- •Known as having an endocervical polyp
- •Known as having infection such as pneumonia, pyelonephritis, septicemia
- •Known as having autoimmune diseases such as systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis
- •Known as having a coagulation defect
- •Known as having severe heart, liver, lung, kidney, or other organ disorder
- •Current or ongoing substance abuse, including alcohol and tobacco, as determined by the Investigator
- •History of chemotherapy or radiotherapy
- •Known allergy or hypersensitivity to dydrogesterone or oral micronized progesterone
- •Use of hCG or dydrogesterone or progesterone within 1 month prior to study enrollment
- •Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic or hospital visits and laboratory tests
- •Any other condition(s) which would make the patient, in the opinion of the Investigator, unsuitable for the study
- •Any other clinical condition(s) that, as judged by the Investigator, contradict(s) inclusion criteria, may lead to early termination of the subject participation in the study, or make it difficult to interpret the results obtained in the study.
结局指标
主要结局
Miscarriage rate before 20 weeks of gestation
时间窗: Week5, Week6, Week8, Week10, Week12, Week14 and Week 18-20 ( Weeks of gestation)
次要结局
- Secondary endpoints(1. Ongoing pregnancy rate at 24 weeks)
研究者
Dr Alka Kriplani
Paras Hospitals