Oral dydrogesterone versus oral micronized progesterone in threatened miscarriage: protocol paper for a randomized controlled trial
Threatened miscarriage is a common complication of early pregnancy characterized by symptoms of vaginal bleeding with/without abdominal cramps/pain in the first trimester. Progestogens are often administered for the management of this condition. Presented herein is the protocol of an ongoing, multic...
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Bioscientifica
2025-02-01
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| Series: | Reproduction and Fertility |
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| Online Access: | https://raf.bioscientifica.com/view/journals/raf/6/1/RAF-24-0044.xml |
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| author | Alka Kriplani Gouri Shankar Kamilya T Ramani Devi Ashima Taneja Amol Pawar Gayathri Karthik Nagesh Tapan Pattanaik Tanusree Gupta Mahima Jain Monjori Mitra |
| author_facet | Alka Kriplani Gouri Shankar Kamilya T Ramani Devi Ashima Taneja Amol Pawar Gayathri Karthik Nagesh Tapan Pattanaik Tanusree Gupta Mahima Jain Monjori Mitra |
| author_sort | Alka Kriplani |
| collection | DOAJ |
| description | Threatened miscarriage is a common complication of early pregnancy characterized by symptoms of vaginal bleeding with/without abdominal cramps/pain in the first trimester. Progestogens are often administered for the management of this condition. Presented herein is the protocol of an ongoing, multicentric clinical trial to investigate the efficacy and safety of micronized progesterone (natural progestogen) compared to dydrogesterone (synthetic isomer of progesterone). A total of 304 eligible pregnant women aged 20–39 years, diagnosed with threatened miscarriage, will be enrolled during 5–12 weeks of gestation and randomized equally to receive either oral dydrogesterone (40 mg stat, followed by 10 mg three times a day) or oral micronized progesterone (200 mg two times a day) up to one week after stoppage of bleeding or if bleeding does not stop, then treatment will be continued till a maximum of 14 weeks of gestation (unless miscarriage is confirmed earlier or the investigator decides to prolong treatment for better outcome or if bleeding relapses). Scheduled visits after enrollment will be conducted during 6–13, 8–14, 18–20 and 24–26 weeks of gestation, in addition to a visit at the end of treatment at 14 weeks and another after parturition. The primary endpoint of the study is the miscarriage rate before 20 weeks of gestation. Secondary endpoints include the ongoing pregnancy rate at 24 weeks, treatment-induced changes in serum levels of cytokines and time to symptom resolution. Apart from the incidence of treatment-emergent adverse events, safety endpoints include changes in complete blood count and the results of liver and kidney function tests from baseline to 14 and 24–26 weeks of gestation. Delivery outcomes are exploratory endpoints of the study. |
| format | Article |
| id | doaj-art-2b833237aa5e4495ab8fd4ed15af2ced |
| institution | Kabale University |
| issn | 2633-8386 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Bioscientifica |
| record_format | Article |
| series | Reproduction and Fertility |
| spelling | doaj-art-2b833237aa5e4495ab8fd4ed15af2ced2025-02-09T12:05:26ZengBioscientificaReproduction and Fertility2633-83862025-02-016110.1530/RAF-24-00441Oral dydrogesterone versus oral micronized progesterone in threatened miscarriage: protocol paper for a randomized controlled trialAlka Kriplani0Gouri Shankar Kamilya1T Ramani Devi2Ashima Taneja3Amol Pawar4Gayathri Karthik Nagesh5Tapan Pattanaik6Tanusree Gupta7Mahima Jain8Monjori Mitra9Department of Obstetrics and Gynecology, Paras Hospitals, Gurugram, Haryana, IndiaDepartment of Obstetrics and Gynecology, IPGME&R and SSKM Hospital, Kolkata, West Bengal, IndiaDepartment of Obstetrics and Gynecology, Ramakrishna Medical Centre LLP, Tiruchirappalli, Tamil Nadu, IndiaDepartment of Obstetrics and Gynecology, Dayanand Medical College & Hospital, Ludhiana, Punjab, IndiaDepartment of Obstetrics and Gynecology, Nowrosjee Wadia Maternity Hospital, Mumbai, Maharashtra, IndiaDepartment of Obstetrics and Gynecology, Manipal Hospital, Bengaluru, Karnataka, IndiaDepartment of Obstetrics and Gynecology, Sum Ultimate Medicare Hospital, Bhubaneswar, Odisha, IndiaDepartment of Gynecology and Obstetrics, Udyan Health Care Pvt. Ltd, Lucknow, Uttar Pradesh, IndiaDepartment of Obstetrics and Gynecology, B. J. Medical College & Civil Hospital, Ahmedabad, Gujarat, IndiaDepartment of Pediatrics, Institute of Child Health, Kolkata, West Bengal, IndiaThreatened miscarriage is a common complication of early pregnancy characterized by symptoms of vaginal bleeding with/without abdominal cramps/pain in the first trimester. Progestogens are often administered for the management of this condition. Presented herein is the protocol of an ongoing, multicentric clinical trial to investigate the efficacy and safety of micronized progesterone (natural progestogen) compared to dydrogesterone (synthetic isomer of progesterone). A total of 304 eligible pregnant women aged 20–39 years, diagnosed with threatened miscarriage, will be enrolled during 5–12 weeks of gestation and randomized equally to receive either oral dydrogesterone (40 mg stat, followed by 10 mg three times a day) or oral micronized progesterone (200 mg two times a day) up to one week after stoppage of bleeding or if bleeding does not stop, then treatment will be continued till a maximum of 14 weeks of gestation (unless miscarriage is confirmed earlier or the investigator decides to prolong treatment for better outcome or if bleeding relapses). Scheduled visits after enrollment will be conducted during 6–13, 8–14, 18–20 and 24–26 weeks of gestation, in addition to a visit at the end of treatment at 14 weeks and another after parturition. The primary endpoint of the study is the miscarriage rate before 20 weeks of gestation. Secondary endpoints include the ongoing pregnancy rate at 24 weeks, treatment-induced changes in serum levels of cytokines and time to symptom resolution. Apart from the incidence of treatment-emergent adverse events, safety endpoints include changes in complete blood count and the results of liver and kidney function tests from baseline to 14 and 24–26 weeks of gestation. Delivery outcomes are exploratory endpoints of the study.https://raf.bioscientifica.com/view/journals/raf/6/1/RAF-24-0044.xmlthreatened miscarriageoral dydrogesteroneoral micronized progesteronepregnancy complicationrandomized controlled trial |
| spellingShingle | Alka Kriplani Gouri Shankar Kamilya T Ramani Devi Ashima Taneja Amol Pawar Gayathri Karthik Nagesh Tapan Pattanaik Tanusree Gupta Mahima Jain Monjori Mitra Oral dydrogesterone versus oral micronized progesterone in threatened miscarriage: protocol paper for a randomized controlled trial Reproduction and Fertility threatened miscarriage oral dydrogesterone oral micronized progesterone pregnancy complication randomized controlled trial |
| title | Oral dydrogesterone versus oral micronized progesterone in threatened miscarriage: protocol paper for a randomized controlled trial |
| title_full | Oral dydrogesterone versus oral micronized progesterone in threatened miscarriage: protocol paper for a randomized controlled trial |
| title_fullStr | Oral dydrogesterone versus oral micronized progesterone in threatened miscarriage: protocol paper for a randomized controlled trial |
| title_full_unstemmed | Oral dydrogesterone versus oral micronized progesterone in threatened miscarriage: protocol paper for a randomized controlled trial |
| title_short | Oral dydrogesterone versus oral micronized progesterone in threatened miscarriage: protocol paper for a randomized controlled trial |
| title_sort | oral dydrogesterone versus oral micronized progesterone in threatened miscarriage protocol paper for a randomized controlled trial |
| topic | threatened miscarriage oral dydrogesterone oral micronized progesterone pregnancy complication randomized controlled trial |
| url | https://raf.bioscientifica.com/view/journals/raf/6/1/RAF-24-0044.xml |
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