Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Cape Town | OTHER |
| Tygerberg Hospital | UNKNOWN |
| Safe Abortion Action Fund of the International Planned Parenthood Federation | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the efficacy of buccal misoprostol cervical priming to laminaria priming among women undergoing D&E at 13-20 weeks gestation in the Western Cape Province, South Africa
As misoprostol is increasingly being used for cervical preparation, concerns about its use and about the proportion of women expelling the fetus prior to the D&E and other side effects mean that rigorous data on possible advantages of osmotic dilators are needed. To address this gap in the literature, we propose to perform an RCT comparing two methods of cervical preparation prior to D&E:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol | Active Comparator |
| |
| Laminaria | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | Misoprostol 400 mcg administered buccally approximately 3-6 hours prior to D&E, repeated once 3 hours after the first dose if needed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of women with fetal expulsion prior to dilation and evacuation | Prior to D&E procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of women requiring additional dilation (manual or pharmacologic) | At time of D&E procedure | |
| Duration of dilation and evacuation procedure | End of D&E procedure | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Judy Kluge, MBChB | Tygerberg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tygerberg Hospital | Cape Town | 7505 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31029655 | Derived | Constant D, Kluge J, Harries J, Grossman D. An analysis of delays among women accessing second-trimester abortion in the public sector in South Africa. Contraception. 2019 Sep;100(3):209-213. doi: 10.1016/j.contraception.2019.04.009. Epub 2019 Apr 25. | |
| 24929888 | Derived | Grossman D, Constant D, Lince-Deroche N, Harries J, Kluge J. A randomized trial of misoprostol versus laminaria before dilation and evacuation in South Africa. Contraception. 2014 Sep;90(3):234-41. doi: 10.1016/j.contraception.2014.05.003. Epub 2014 May 14. |
| Label | URL |
|---|---|
| Click here to visit the Ibis Reproductive Health website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
Not provided
Not provided
| Society of Family Planning |
| OTHER |
Not provided
Not provided
Not provided
Not provided
| Laminaria | Device | Laminaria tents inserted into the cervix 18 to 24 hours prior to D&E |
|
| Frequency of major complications |
Major complications to include:
|
| Recorded at TOP visit and/or follow-up visit (target 7 days after procedure) |
| Frequency of Minor Complications | Minor complications to include:
| Recorded at TOP visit and/or follow-up visit (target 7 days after procedure) |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |