Techniques to Improve Efficacy of Second Trimester Medical Termination

Pregnancy Clinical Trial

Official title:

Comparison of 3 Regimens Using Mifepristone and Misoprostol for Second Trimester Pregnancy Interruption.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00864799
• Other study ID #: 1624/EW
• Status: Completed
• Phase: N/A
• First received: March 18, 2009
• Last updated: July 23, 2013
• Start date: April 2009
• Est. completion date: March 2013

Study information

• Verified date: July 2013
• Source: King Edward Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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 (Therapeutic Goods Administration) 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.

Description:

Aims:

1. 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.

2. To compare the impact of gestation of the duration of abortion within these three misoprostol regimens.

3. To compare the incidence of maternal side-effects between the three routes of prostaglandin administration.

4. To compare the incidence of placental retention and need for curettage between the three groups

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• Misoprostol
Comparison of 3 routes of administration of misoprostol for termination of pregnancy 14-24 weeks

Locations

Country	Name	City	State
Australia	King Edward Memorial Hospital	Perth	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
King Edward Memorial Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Induction to delivery interval	No
Secondary	To compare the incidence of maternal side-effects between the three routes of prostaglandin administration.		Admission to hospital discharge	Yes
Secondary	To compare the incidence of placental retention and need for curettage between the three groups		Delivery of fetus to delivery of placenta interval	Yes
Secondary	To compare the impact of gestation of the duration of abortion within these three misoprostol regimens.		Interval from commencement of prostaglandin to delivery of fetus	No