Maternal & Neonatal Health

Issues in Establishing Postabortion Care Services in Low-Resource Settings: Workshop Presentations

Use of Misoprostol for the Management
of Bleeding in Early Pregnancy (continued)

Fredrik F. Broekhuizen, MD

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Remaining Questions

placeholderplacehol Many questions remain. What is the ideal dosing? What is the best route? What is the blood loss? What is the optimal timeframe for medical management in a low-resource setting—24 or 48 hours? How does one establish the diagnosis? By ultrasound — impractical in remote settings — or by clinical criteria as one does for MVA now?

Misoprostol for Incomplete Abortion: Study Design Issues
  • Clinical versus ultrasound diagnosis:
    • Less than 50 mm POC on ultrasonography probably do not need any evacuation.
  • Dosages and route of administration?
  • Establish similar safety profile as MVA or prove superior performance?
  • Analyze cost differences?

Medical management has not been compared with MVA in a PAC setting with healthcare workers other than physicians. There clearly is a need for prospective randomized trials comparing medical management using misoprostol against MVA, with more outcome parameters than so far have been studied (see below).

Misoprostol for Incomplete Abortion: Study Design
  • Clinical diagnosis of incomplete/missed abortion
    • Open os
    • Bleeding
    • POC visible
    • < 12 weeks age of gestation
  • Choose between 3–4 arms
    • Expectant
    • Misoprostol
      • 400 mcg every 4 hours
      • 800 mcg every 8 hours
    • MVA
  • After 24–48 hours: MVA in all groups
  • Outcome parameters
    • Blood loss > 500 cc
    • Change in hematocrit
    • Infection
    • Perforation
    • Repeat MVA
    • Missed ectopic

Blood loss, need for transfusion, change in hematocrit, missed ectopic pregnancy, repeat MVA, infection rate and cost also need to be examined. Ultrasound diagnosis versus clinical diagnosis may be compared. If close observation is possible, expectant management could be a third arm. If these studies confirm the value and cost-effectiveness of medical management of incomplete abortion with misoprostol, one can envision the diagnosis made by a primary healthcare worker in the field. Misoprostol would be initiated as the first line treatment and MVA would be available as a "scheduled" back up within a given timeframe if a MVA site were close, or as an "urgent/emergent back up" if misoprostol were ineffective within a given timeframe.

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Summary

Most studies of misoprostol have established its safety and cost-effectiveness for termination of early pregnancies and resolution of missed abortions, either as a single drug or used in conjunction with other agents. In this context, misoprostol has been found effective in evacuating retained products of conception in 70–80 percent of cases, resulting in an overall reduction of blood loss. Given such potential, misoprostol potentially could be useful as a first-line agent in cases of incomplete abortion: to control uterine bleeding while waiting for the evacuation to occur either spontaneously or assisted by MVA in a healthcare setting.

Because the majority of these deaths occur at the level where emergency medical care is not available, misoprostol in the hands of primary healthcare providers may be a practical, accessible "life saver" at a low cost. Before this can happen, however, additional studies must be undertaken in diverse healthcare settings to answer key questions posed in this paper.

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References

Carbonell JL et al. 1997a. Misoprostol 3, 4 or 5 days after methotrexate for early abortion. Contraception 56: 169–174.

Carbonell JL et al. 1997b. The use of misoprostol for abortion at < 9 weeks’ gestation. European Journal of Contraception and Reproductive Health Care 2(3): 181–185.

Chipcase J and D James. 1997. Randomised trial of expectant versus surgical management of spontaneous miscarriage. British Journal of Obstetrics and Gynaecology 104(7): 840–841.

Chung T et al. 1997. A medical approach to management of spontaneous abortion using misoprostol. Extending misoprostol treatment to a maximum of 48 hours can further improve evacuation of retained products of conception in spontaneous abortion. Acta Obstetricia Gynecologica Scandinavica 76(3): 248–251.

Chung TK et al. 1995. Misoprostol in the management of spontaneous abortion. British Journal of Obstetrics and Gynaecology 102(10): 832–835.

Chung TK et al. 1994. Spontaneous abortion: A medical approach to management. Australian and New Zealand Journal of Obstetrics and Gynaecology 34(4): 432–436.

Creinin MD, R Moyer and R Guido. 1997. Misoprostol for medical evacuation of early pregnancy failure. Obstetrics and Gynecology 89(5, Pt. 1): 768–772.

El Refaey H et al. 1995. Induction of abortion with mifepristone (RU 486) and oral or vaginal misoprostol. New England Journal of Medicine 332: 983–987.

Faundes A et al. 1996. Postabortion complications after interruption of pregnancy with misoprostol. Advances in Contraception 12(1): 1–9.

Fong YF, K Singh and RN Prasad. 1998. A comparative study using two dose regimens (200 microg or 400 microg) of vaginal misoprostol for pre-operative cervical dilatation in first trimester nulliparae. British Journal of Obstetrics and Gynaecology 105(4): 413–417.

Gonzalez CH et al. 1998. Congenital abnormalities in Brazilian children associated with misoprostol misuse in first trimester pregnancy. Lancet 351(9116): 1624–1627.

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Henshaw RC et al. 1993. Medical management of miscarriage: Non-surgical uterine evacuation of incomplete and inevitable spontaneous abortion. British Medical Journal 306(6882): 894–895.

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Hofmeyr GJ et al. 1998. Limb reduction anomaly after failed misoprostol abortion. South Africa Medical Journal 88(5): 566–567.

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Nielsen S and M Hahlin. 1995. Expectant management of first-trimester spontaneous abortion. Lancet 345(8942): 84–86.

Pastuszak AL et al. 1998. Use of misoprostol during pregnancy and Moebius syndrome in infants. New England Journal of Medicine 338(26): 1881–1885.

Zeiman M et al. 1997. Absorption kinetics of misoprostol with oral or vaginal administration. Obstetrics and Gynecology 90(1): 88–92.

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