Techniques to Improve Efficacy of Second Trimester Medical Termination
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Interruption of a pregnancy after 14 weeks gestation may be required when the fetus is dead, severely malformed or in cases of maternal illness. This process is usually conducted medically in Australia, using the synthetic prostaglandin E1 analogue misoprostol. This prostaglandin, although not licensed for use in pregnancy termination, is now a common abortifacient with a large accumulated experience both within Australia and internationally. Since 1996, misoprostol has been used at King Edward Memorial Hospital as the principal agent for second trimester pregnancy termination.
Misoprostol may be administered vaginally, orally, sublingually or buccally in the process of pregnancy termination. Each route of administration has its own advantages and disadvantages. The most appropriate route of administration, with the shortest duration of abortion and lowest side-effect profile has not been determined for all circumstances.
The combination of mifepristone and misoprostol is an established and effective method for second trimester pregnancy termination. Prior studies have demonstrated a significant reduction in the duration of abortion with misoprostol when mifepristone priming is used. In November 2007, the TGA approved an application by the Principal Investigator of this planned study for Authorised Prescriber status for use of the antiprogesterone agent mifepristone. Since January 2008 the combination of mifepristone and misoprostol has been used at KEMH for first and second trimester pregnancy termination of pregnancy, predominantly for circumstances of severe fetal abnormality.
There is however limited data on the impact of gestation on the duration of second trimester termination. Almost all published studies to date have recruited women in the early second trimester (typically with a median of 16 weeks gestation). However, most terminations of pregnancy for fetal abnormality (the most frequent reason for pregnancy interruption of a live fetus at KEMH) occur at 18-24 weeks gestation. The investigators' experience indicates a significant impact of increasing gestation with prolongation of the duration of pregnancy termination. In this study the investigators aim to evaluate three misoprostol regimens for second trimester pregnancy termination following mifepristone priming with the primary intention to develop a protocol which results in a delivery rate within 24 hours for 95% of women at gestations <24 weeks.
Secondary aims of this study will be to assess the incidence of maternal side-effects for each of the three regimens, the placental retention rates and the need for curettage for retained placental tissue. As the investigators will be using 3 different methods of misoprostol administration, the investigators will also review women's satisfaction with the three regimens for pregnancy termination.
| Condition | Intervention |
|---|---|
|
Pregnancy |
Drug: Misoprostol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of 3 Regimens Using Mifepristone and Misoprostol for Second Trimester Pregnancy Interruption. |
- To compare the efficacy of the vaginal and sublingual administration of the synthetic prostaglandin misoprostol with the currently used oral administration route in second trimester pregnancy termination. [ Time Frame: Induction to delivery interval ] [ Designated as safety issue: No ]
- To compare the incidence of maternal side-effects between the three routes of prostaglandin administration. [ Time Frame: Admission to hospital discharge ] [ Designated as safety issue: Yes ]
- To compare the incidence of placental retention and need for curettage between the three groups [ Time Frame: Delivery of fetus to delivery of placenta interval ] [ Designated as safety issue: Yes ]
- To compare the impact of gestation of the duration of abortion within these three misoprostol regimens. [ Time Frame: Interval from commencement of prostaglandin to delivery of fetus ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 312 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Vaginal misoprostol
Women allocated to the vaginal misoprostol management protocol will receive a loading dose of 800 mcg misoprostol vaginally followed in 4 hours by 400 mcg vaginal misoprostol, the latter repeated every 4 hours for a maximum of 4 doses. If abortion does not occur within 24 hours of commencement of this regimen, the sequence will be repeated. If delivery is not accomplished within 48 hours of prostaglandin commencement, a transcervical Foley catheter will be inserted and a solution of prostaglandin F2 alpha infused 2-hourly until delivery occurs. |
Drug: Misoprostol
Comparison of 3 routes of administration of misoprostol for termination of pregnancy 14-24 weeks
|
|
Active Comparator: Oral misoprostol
Women allocated to the standard management protocol will receive a loading dose of 800 mcg misoprostol vaginally followed in 3 hours by 400 mcg misoprostol orally, the latter repeated every 3-hours to a maximum of 4 oral doses. If abortion does not occur within 24 hours of commencement of this regimen, the sequence will be repeated. If delivery is not accomplished within 48 hours of prostaglandin commencement, a transcervical Foley catheter will be inserted and a solution of prostaglandin F2 alpha infused 2-hourly until delivery occurs. |
Drug: Misoprostol
Comparison of 3 routes of administration of misoprostol for termination of pregnancy 14-24 weeks
|
|
Active Comparator: Sublingual misoprostol
Women allocated to the sublingual misoprostol protocol will receive a loading dose of 800 mcg misoprostol vaginally followed in 3 hours by 400 mcg sublingual misoprostol, the latter repeated every 3 hours for a maximum of 4 doses. If abortion does not occur within 24 hours of commencement of this regimen, the sequence will be repeated. If delivery is not accomplished within 48 hours of prostaglandin commencement, a transcervical Foley catheter will be inserted and a solution of prostaglandin F2 alpha infused 2-hourly until delivery occurs. |
Drug: Misoprostol
Comparison of 3 routes of administration of misoprostol for termination of pregnancy 14-24 weeks
|
Detailed Description:
Aims:
- To compare the efficacy of the vaginal and sublingual administration of the synthetic prostaglandin misoprostol with the currently used vaginal administration route in second trimester pregnancy termination.
- To compare the impact of gestation of the duration of abortion within these three misoprostol regimens.
- To compare the incidence of maternal side-effects between the three routes of prostaglandin administration.
- To compare the incidence of placental retention and need for curettage between the three groups
Eligibility| Ages Eligible for Study: | 16 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 14-24 weeks pregnant
- planned medical termination
- able to speak and understand English
- no contraindication to prostaglandins
Exclusion Criteria:
- gestation < 13 weeks
- allergy/contraindication to misoprostol
- allergy/contraindication to mifepristone
- fetal demise
Contacts and Locations| Contact: Jan E Dickinson, MD | 61-8-93401330 | Jan.Dickinson@uwa.edu.au |
| Australia, Western Australia | |
| King Edward Memorial Hospital | Recruiting |
| Perth, Western Australia, Australia, 6008 | |
| Contact: Jan E Dickinson, MD 61-8-9340 1330 Jan.Dickinson@uwa.edu.au | |
| Principal Investigator: Jan E Dickinson, MD | |
| Principal Investigator: | Jan E Dickinson, MD | The University of Western Australia |
More Information
No publications provided
| Responsible Party: | Prof Jan Dickinson, The University of Western Australia |
| ClinicalTrials.gov Identifier: | NCT00864799 History of Changes |
| Other Study ID Numbers: | 1624/EW |
| Study First Received: | March 18, 2009 |
| Last Updated: | June 29, 2009 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by King Edward Memorial Hospital:
|
Abortion Misoprostol Mifepristone Pregnancy Fetus |
Additional relevant MeSH terms:
|
Mifepristone Misoprostol Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptives, Postcoital, Synthetic |
Contraceptives, Postcoital Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Menstruation-Inducing Agents Abortifacient Agents, Steroidal Abortifacient Agents Anti-Ulcer Agents Gastrointestinal Agents Oxytocics Abortifacient Agents, Nonsteroidal |
ClinicalTrials.gov processed this record on June 18, 2013