Early intrauterine pregnancy failure: A randomized trial of medical versus surgical treatment

doi:10.1067/mob.2002.126205

American Journal of Obstetrics and Gynecology

Volume 187, Issue 2, August 2002, Pages 321-326

Presented at the Annual Meeting of the South Atlantic Association of Obstetricians and Gynecologists, St Petersburg, Fla, January 27-30, 2002.

https://doi.org/10.1067/mob.2002.126205 Get rights and content

Abstract

Objective: The purpose of this study was to determine whether medical treatment of early pregnancy failure represents a reasonable alternative to surgical therapy. Study Design: Patients who were diagnosed with pregnancy failure before 12 weeks of gestation were randomly assigned to receive either medical (intravaginal misoprostol) or surgical therapy (dilatation and curettage). In the medical arm of the study, 800 μg of misoprostol was placed within the posterior vaginal fornix. Patients subsequently were seen 24 and 48 hours after the initial dosing; intravaginal misoprostol was readministered only if ultrasound images revealed evidence of persistent pregnancy tissue. By 72 hours after initial study entry, if either a gestational sac or placental tissue was present, the medical treatment was considered a failure, and uterine curettage was performed. Statistical analysis was performed with the two-tailed unpaired t test, χ² analysis, Fisher exact test, and Mann-Whitney U test; a probability value of <.05 was considered statistically significant. Results: A total of 50 women were enrolled, with 2 patients in the surgical arm experiencing spontaneous pregnancy loss before their scheduled procedures. Twenty-five women received medical therapy; 25 women were randomized to surgical procedure. Fifteen patients in the medical group (60%; 95% CI, 0.41-0.79) had successful pregnancy termination and did not require curettage. There were no significant differences between the medical and surgical groups with respect to either posttreatment hematocrit level or the time needed to achieve negative human chorionic gonadotropin test results. Conclusion: Intravaginal misoprostol is an effective agent for the treatment of early pregnancy failure. Medical treatment of early pregnancy failure represents a reasonable alternative to immediate surgical therapy. (Am J Obstet Gynecol 2002;187:321-6.)

Section snippets

Material and methods

This clinical study was conducted between June 1999 and March 2000 at Naval Medical Center Portsmouth. The study protocol had received approval from the Clinical Investigation and Review Department before patient enrollment. All subjects were thoroughly counseled with regards to potential risks, and written informed consent was obtained before study participation.

Women, aged 18 to 50 years, with proved failed intrauterine pregnancies were eligible for entry into the study. Patients were

Results

Twenty-five women were placed randomly in the medical arm of the study, and 25 women were placed randomly in the surgical arm. Two patients in the surgical arm had spontaneous pregnancy loss before their scheduled procedures. All but 2 of the subjects had a complete postprocedure evaluation. Both these individuals were lost to follow-up because of military transfers. One patient was in the surgical arm, and one patient was in the medical group. The last hCG values obtained for these 2 patients

Comment

Using a combination of the terms surgery, medical, curettage, misoprostol, missed abortion, early pregnancy failure, miscarriage, spontaneous abortion, and treatment, we searched the English language literature from 1980 to 2001 on MEDLINE. There have been several clinical trials that have evaluated the efficacy of medical treatment for the evacuation of the first-trimester uterus.7, 8 Although there were several studies that included patients with either incomplete abortion or spontaneous

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Cited by (65)

Expectant vs medical management for retained products of conception after medical termination of pregnancy: a randomized controlled study
2022, American Journal of Obstetrics and Gynecology
Despite the rise of medical treatments for the termination of pregnancy, to date, no prospective trial has evaluated the efficacy of misoprostol in treating retained products of conception after induced termination of pregnancy.
This study aimed to compare medical management with misoprostol with expectant management for retained products of conception after first-trimester medical termination of pregnancy.
This was an open-label randomized controlled trial conducted at a university-affiliated tertiary medical center. Consenting consecutive women who underwent a routine 3-week follow-up evaluation after medical termination of pregnancy and had a sonographic suspicion of retained products of conception, defined as sonographic evidence of intrauterine remnant (>12 mm) with a positive Doppler flow, were recruited. The participants were randomized into a medical treatment group (800 μg of sublingually administered misoprostol) or expectant management. They all underwent repeat ultrasound scans every 2 weeks until a maximum of 6 weeks, and those suspected of persistent retained products of conception were referred to operative hysteroscopy. The primary endpoint was successful treatment defined as no need for surgical intervention because of persistent retained products of conception within 8 weeks from pregnancy termination.
There was no marked difference in demographic characteristics between the study groups. The median sonographically demonstrated retained product length was 20 mm (interquartile range, 17–25) in the medically managed group compared with 20 mm (interquartile range, 17–26) in the expectantly managed group (P=.733). Treatment succeeded in 42 of 68 women (61.8%) in the medically managed group compared with 36 of 63 women (57.1%) in the expectantly managed group (relative risk, 1.12; 95% confidence interval, 0.74–1.70; P=.590). There was no difference in adverse outcomes between the 2 groups.
There was no clinically meaningful advantage for medical treatment with misoprostol compared with expectant management after first-trimester medical termination of pregnancy in women with suspected retained products of conception. Surgical intervention can be avoided in up to 60% of women who are managed expectantly for 8 weeks of follow-up.
Early Pregnancy Failure
2019, Fetal Medicine: Basic Science and Clinical Practice
Increasing the management options for early pregnancy loss: The economics of miscarriage
2015, American Journal of Obstetrics and Gynecology
Sequential use of mifepristone and misoprostol in treatment of early pregnancy failure appears more effective than misoprostol alone: A retrospective study
2014, European Journal of Obstetrics and Gynecology and Reproductive Biology
Is treatment of early pregnancy failure (EPF) with sequential use of mifepristone and misoprostol more effective than treatment with misoprostol alone?
In a retrospective cohort study at the Department of Obstetrics and Gynaecology of the Radboud University Medical Centre, 301 women with early pregnancy failure receiving medical treatment between January 2008 and March 2013 were included. Of these, 199 women were pre-treated with 200 mg mifepristone (orally) followed by 2 consecutive doses of 800 mcg misoprostol (vaginally) and 102 women were treated with 2 consecutive doses of 800 mcg misoprostol (vaginally) alone.
Complete expulsion was achieved in 66.8% of the women treated with a sequential combination of mifepristone and misoprostol versus 54.9% of the women treated with misoprostol alone. The difference in rates of complete expulsion was 11.9% (P < 0.05; 95% CI 0.3–23.6%).
Medical treatment of early pregnancy failure with a sequential combination of mifepristone and misoprostol was more effective than treatment with misoprostol alone. Our findings will have to be confirmed by a large prospective multicentre double blinded-randomized trial.
Clinical and ultrasonographic factors affecting successful medical treatment of early pregnancy failure
2012, Gynecologie Obstetrique et Fertilite
Évaluer les facteurs cliniques et échographiques influençant l’efficacité du misoprostol pour traiter une grossesse arrêtée (GA) au premier trimestre.
Il s’agit d’une étude observationnelle unicentrique du 01/06/00 au 15/05/2010. Elle incluait les patientes présentant une GA inférieure à 12 semaines d’aménorrhée (SA) en échographie. Le traitement était l’administration de 800 μg de misoprostol en intravaginal. Le succès était défini par une épaisseur endométriale inférieure à 15 mm en échographie 24 heures après le traitement. En cas d’échec, une aspiration endo-utérine (AEU) était réalisée. Les variables étudiées étaient cliniques (âge, date des dernières règles, gestité, parité, antécédents de fausse couche, d’aspiration endoutérine, grossesse extra-utérine [GEU], accouchement voie basse et de césariennes) et échographiques (absence ou présence d’un embryon, longueur crânio-caudale, taille du sac gestationnel).
Nous avons inclus 501 patientes. Le taux de succès (TS) était de 336/501 (67,1 %). En analyse univariée, la parité et le nombre de césariennes moyens étaient plus élevés en cas d’échec (p = 0,048 et p = 0,002). L’antécédent d’une ou plusieurs césarienne(s) était un facteur de risque d’échec significatif (p = 0,001). Il n’existait pas de différence significative pour les autres critères. En analyse multivariée, le nombre moyen de césariennes (p = 0,003) et l’antécédent d’une ou plusieurs césarienne(s) restaient significatifs (p = 0,002).
Les critères échographiques et l’âge gestationnel n’influencent pas l’efficacité du misoprostol dans le traitement des grossesses arrêtées du premier trimestre. Le taux de réussite est significativement diminué par l’antécédent d’une ou plusieurs césariennes. Ce résultat doit être confirmé par d’autres études. Il constitue une aide à la décision thérapeutique pour la patiente et le médecin en cas de GA.
To assess clinical and echocardiographic factors impacting the effectiveness of misoprostol in early pregnancy failure.
An observational study was carried out within the gynaecological emergency service from 01/06/2000 to 15/05/2010. Patients had pregnancy failure in the first 12 weeks at ultrasonic examination. The patient received 4 misoprostol tablets (800 μg) intravaginally with clinical and ultrasound examination 24 hours later. The treatment was considered effective if the endometrial thickness was lower than 15 mm by ultrasound examination and absence of secondary endo-uterine aspiration. If the treatment was considered as a failure, an endo-uterine aspiration was carried out. Variables studied were clinical (patient age, date of the last menstrual period, gravidity, parity, history of miscarriage, endouterine aspiration, ectopic pregnancy, vaginal delivery, caesarean section) and ultrasound-based (presence or absence of an embryo, CRL, gestational sac diameter).
Five hundred and one patients were included. The success rate was 336/501 (67.1%). After univariate analysis, the averages of parity (P = 0.048) and caesarean section (P = 0.002) were significantly higher in failure cases. The history of one or more caesarean section was a significant risk factor for failure (P = 0.001). There was no significant difference for the other criteria. In multivariate analysis, the average number of caesarean sections (P = 0.003) and the history of one or more caesarean section remained significant (P = 0.002).
The ultrasound criteria and gestational age do not impact the effectiveness of misoprostol in the treatment of early pregnancy failure. The history of one or more caesarean section (s) significantly decreased the success rate. It has to be confirmed by other studies. This new data can be an aid to decision-making for the patient and the physician in case of early pregnancy failure.
Oral misoprostol as an alternative to surgical management for incomplete abortion in Ghana
2011, International Journal of Gynecology and Obstetrics
Citation Excerpt :
Such treatment with misoprostol—a low-cost, “one-stop,” non-surgical method—could be an important addition to postabortion care services because it is inexpensive and can be administered by mid-level providers, thus facilitating access to care. Previous reports have shown that misoprostol is effective at evacuating the uterus following incomplete abortion, with success rates ranging from 60%–95% [5–17]. Research conducted in Burkina Faso, Mozambique, and Tanzania has provided evidence that a single dose of 600-μg oral misoprostol is as safe and effective as manual vacuum aspiration (MVA) when used for uterine evacuation [17–21].
To investigate whether 600-μg oral misoprostol is an effective alternative to manual vacuum aspiration (MVA) for the treatment of incomplete abortion.
From June 16, 2004, to July 20, 2005, 230 women of reproductive age presenting with incomplete abortion were randomized in an open-label trial to either 600-μg oral misoprostol or MVA for the treatment of incomplete abortion.
Regardless of the assigned method, more than 98% of participants experienced complete uterine evacuation following initial treatment. Efficacy, acceptability, and satisfaction ratings were similar and high for both methods.
600-μg oral misoprostol is a safe, effective, and acceptable alternative to MVA for the treatment of incomplete abortion.

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^☆: Supported by the Chief, Navy Bureau of Medicine and Surgery, Washington DC, Clinical Investigation Program (CIP No. 99-037).

^☆☆: The views expressed in this article are those of the authors and do not reflect the official position of the Department of Defense, the Department of the Navy, or the United States Government.

^★: Reprints not available from the authors.

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Transactions of the Sixty-fourth Annual Meeting of the South Atlantic Association of Obstetricians and GynecologistsEarly intrauterine pregnancy failure: A randomized trial of medical versus surgical treatment☆,☆☆,★

Abstract

Section snippets

Material and methods

Results

Comment

Obstet Gynecol

Am J Obstet Gynecol

Ann Emerg Med

Am J Obstet Gynecol

Obstet Gynecol

Obstet Gynecol

Obstet Gynecol

Am J Obstet Gynecol

Obstet Gynecol

Am J Obstet Gynecol

Am J Obstet Gynecol

Fertil Steril

Transactions of the Sixty-fourth Annual Meeting of the South Atlantic Association of Obstetricians and Gynecologists
Early intrauterine pregnancy failure: A randomized trial of medical versus surgical treatment☆,☆☆,★