Chinese Herbal Medicine (New "Shoutai Wan") and/or Oral Progesterone Intervention Trial for Threatened Miscarriage
- Conditions
- Threatened Miscarriage
- Interventions
- Drug: Chinese Herbal Medicine (New "Shoutai Wan") plus Oral ProgesteroneDrug: Chinese Herbal Medicine (New "Shoutai Wan") plus Oral Progesterone PlaceboDrug: Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo) plus Oral ProgesteroneDrug: Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo) plus Oral Progesterone Placebo
- Registration Number
- NCT02633878
- Lead Sponsor
- Heilongjiang University of Chinese Medicine
- Brief Summary
Threatened miscarriage is manifested by vaginal bleeding, with or without abdominal pain, while the cervix is closed and the fetus is viable and inside the uterine cavity. Threatened miscarriage is a common complication of pregnancy occurring in 20% of all clinically recognized pregnancies and about half of these will eventually result in pregnancy loss. The goal of this two by two factorial, placebo controlled randomized trial is to determine that two oral medications and their combination, will mostly likely result in live birth in women with threatened miscarriage. We will evaluate the efficacy and safety of Chinese herbal medicine (New "Shoutai Wan", NSTW) and/or oral micronized progesterone (OP) for treating threatened miscarriage in this trial. Our primary outcome of this trial is live birth. We hypothesize that: 1. treatment with NSTW plus OP or OP placebo is more likely to result in live birth than NSTW placebo plus OP or placebo; 2. treatment with OP plus NSTW or NSTW placebo is more likely to result in live birth than OP placebo plus NSTW or NSTW placebo; 3. treatment with combination of NSTW and OP is more likely to result in live birth than combination of NSTW placebo and OP placebo.
- Detailed Description
The causes of spontaneous miscarriage are diverse and comprise chromosomal, genetic, anatomical, immunological, hormonal, infectious and psychological factors, the other factors contribute to an increased risk include advancing paternal and maternal age and mothers with systemic diseases, such as diabetes or thyroid dysfunction. The incidence is difficult to determine precisely because it occurs very early during a pregnancy and almost 30% of early pregnancy may go unrecognized; the pathogenesis of pregnancy loss in this condition is still remains obscure. Compared with healthy women, the women with threatened miscarriage were found not only to have increased rate of antepartum haemorrhage, prelabour rupture of the membranes, preterm delivery, and intrauterine growth restriction, but also suffer from significant psychological impairment including considerable anxiety and stress, depression, sleep disturbances, anger, and marital disturbances.
To date, therapies have limited effectiveness in treating threatened miscarriage and are empirical. Bed rest does not prevent pregnancy loss. Acetaminophen may have some effects on relieving pain only. The most commonly used prescription medication was human chorionic gonadotropin (hCG), maintaining the luteotrophic effects to support continued secretion of estrogen and progesterone, but it's beneficial effects still cannot be verified. Progesterone is another most commonly used standard medication, maintaining the endometrial proliferation and preventing poor decidualization. A number of recent studies in women with threatened miscarriage shown a reduction in pregnancy loss with progesterone treatment. But progestogens are a group of hormones, including both the natural female sex hormone progesterone and the synthetic forms. Micronized progesterone is a kind of progesterone; it is structurally and pharmacologically very similar to natural progesterone and has good oral bioavailability. It is especially suitable for women with threatened miscarriage as it does not have androgenic or oestrogenic effects on the foetus. A recent review of maternal use of micronized progesterone during pregnancy also found no evidence for an increased risk of congenital malformations. However it may only be suitable to treat women with threatened miscarriage who have low progesterone levels due to corpus luteum deficiency at the first trimester of pregnancy. There is no evidence to show the beneficial effects of progesterone to treat threatened miscarriage due to others factors. At the same time, progesterone treatment is also expensive. New or adjuvant treatments that are suitable, readily accessible, affordable, and safe are needed to treat women with threatened miscarriage.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1656
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description NSTW + OP Chinese Herbal Medicine (New "Shoutai Wan") plus Oral Progesterone NSTW one pack twice daily until 12 weeks of gestations (max 84 days); OP 100 mg thrice daily until 12 weeks of gestations (max 84 days). NSTW + OP placebo Chinese Herbal Medicine (New "Shoutai Wan") plus Oral Progesterone Placebo NSTW one pack twice daily until 12 weeks of gestations (max 84 days); OP Placebo 100 mg thrice daily until 12 weeks of gestations (max 84 days). NSTW Placebo + OP Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo) plus Oral Progesterone NSTW Placebo one pack twice daily until 12 weeks of gestations (max 84 days); OP 100 mg thrice daily until 12 weeks of gestations (max 84 days). NSTW Placebo + OP Placebo Chinese Herbal Medicine Placebo (New "Shoutai Wan" placebo) plus Oral Progesterone Placebo NSTW Placebo one pack twice daily until 12 weeks of gestations (max 84 days); OP Placebo 100 mg thrice daily until 12 weeks of gestations (max 84 days).
- Primary Outcome Measures
Name Time Method Live birth At or beyond 20 completed weeks' gestation Rate of live birth at or beyond 20 completed weeks' gestation
- Secondary Outcome Measures
Name Time Method Pregnancy outcome: Ongoing pregnancy Beyond 12 weeks' gestation Rate of ongoing pregnancy (beyond 12 weeks' gestation)
Pregnancy outcome: Miscarriage during the first trimester During the first trimester (at or before 12 weeks' gestation) Rate of miscarriage during the first trimester (at or before 12 weeks' gestation)
Pregnancy outcome: Miscarriage during second and third trimesters During second and third trimesters (beyond 12 weeks' gestation until 20 weeks) Rate of miscarriage during second and third trimesters (beyond 12 weeks' gestation until 20 weeks)
Pregnancy outcome: Termination At any time during treatment (up to 2 months) and follow-up period (up to 1 year) Rate of termination at any time during treatment and follow-up period
Pregnancy outcome: Stillbirth At or beyond 20 weeks' gestation Rate of stillbirth (at or beyond 20 weeks' gestation)
Pregnancy outcome: Induced abortion At any time during treatment (up to 2 months) and follow-up period (up to 1 year) Rate of induced abortion at any time during treatment and follow-up for any reasons
Pregnancy outcome: Gestational age at delivery Up to 1 day after delivery Gestational age at delivery (weeks and days)
Pregnancy outcome: Preterm birth Birth before 37 completed weeks' gestation (up to and including 36 weeks and 6 days of gestation) Rate of preterm birth (birth beyond 28 week and before 37 completed weeks' gestation (up to and including 36 weeks and 6 days of gestation))
Pregnancy outcome: Extreme preterm birth Birth beyond 20 weeks and before 28 completed weeks' gestation (up to and including 27 weeks and 6 days of gestation) Rate of extreme preterm birth (birth beyond 20 weeks and before 28 completed weeks' gestation (up to and including 27 weeks and 6 days of gestation))
Pregnancy outcome: Full-term birth At or beyond 37 weeks' gestation, and before 42 weeks' gestation Rate of full-term birth (at or beyond 37 weeks' gestation, and before 42 weeks' gestation)
Pregnancy outcome: Post-term birth At or beyond 42 weeks' gestation Rate of post-term birth (at or beyond 42 weeks' gestation)
Neonatal outcome: Birth weight When neonatal is born Birth weight of neonatal (adjusted for gestational age and sex by Chinese standards)
Neonatal outcome: Small for gestational age When neonatal is born Rate of small for gestational age when neonatal is born
Neonatal outcome: Large for gestational age When neonatal is born Rate of large for gestational age when neonatal is born
Neonatal outcome: Congenital malformation At any time during treatment (up to 2 months) and follow-up period (up to 1 year) Rate of congenital malformation
Other outcome: Mean score change in TCM Symptom Questionnaire From date of randomization until the date of end of treatment, assessed up to 2 months Mean score change in TCM Symptom Questionnaire from baseline to the end of intervention. The questionnaire covers many dimensions including symptoms (amount of vaginal bleeding, severity of abdominal pain and other general symptoms), emotional factors and so on. The minimum and maximum value are depend on the symptoms of the patient respectively.
Other outcome: Mean score change in 12-Item Short-Form Health Survey From date of randomization until the date of end of treatment, assessed up to 2 months Mean score change in 12-Item Short-Form Health Survey from baseline to the end of intervention. The minimum value is 0 and the maximum value is 100, and higher scores mean a better outcome.
Other outcome: Mean score change in Self-Rating Anxiety Scale From date of randomization until the date of end of treatment, assessed up to 2 months Mean score change in Self-Rating Anxiety Scale from baseline to the end of intervention. The minimum value is 20 and the maximum value is 80, and lower scores mean a better outcome.
Trial Locations
- Locations (22)
The First Affiliated Hospital of Anhui University of Chinese Medicine
🇨🇳Hefei, Anhui, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Da Qing Long Nan Hospital
🇨🇳Daqing, Heilongjiang, China
Luoyang Hospital of Traditional Chinese Medicine
🇨🇳Luoyang, Henan, China
The First Affiliated Hospital of Hunan University of Chinese Medicine
🇨🇳Changsha, Hunan, China
Changzhou Hospital of Traditional Chinese Medicine
🇨🇳Changzhou, Jiangsu, China
Suqian Maternity Hospital
🇨🇳Suqian, Jiangsu, China
The People's Hospital of Siyang
🇨🇳Suqian, Jiangsu, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
Jiangxi Maternity and Child Health Hospital
🇨🇳Nanchang, Jiangxi, China
Scroll for more (12 remaining)The First Affiliated Hospital of Anhui University of Chinese Medicine🇨🇳Hefei, Anhui, China