Cytotec for labor induction

The off-label-use of Cytotec from Pfizer (generic name: misoprostol) for labor induction was common practise in German hospitals. In some papers this off-label-use is classified as a treatment mistake that may lead to liability consequences for the physician. This article broaches this issue of malpractice considering German liability and case law.

Objective To determine if outpatient cervical ripening with daily misoprostol can reduce admission to delivery time in women with low-risk pregnancies at 39 or more weeks of gestation. Study design This is a retrospective cohort study of a convenience sample of low-risk pregnancies that underwent elective outpatient cervical ripening compared to matched controls for parity (nulliparous vs. parous) and gestational age. Time from admission to delivery, induction agents, presence of tachysystole, mode of delivery, length of hospitalization, neonatal intensive care unit (NICU) admission, and low Apgar scores were compared...

BACKGROUND: Although labor induction is a commonly used procedure in obstetrical care, there are limited data on its psycho-emotional effects on the woman. This study analysed the expectations and experiences of women in different routes of labor induction. The study's primary aim was to compare women's delivery experience if induced by orally administrated misoprostol (OMS) compared with misoprostol vaginal insert (MVI). Secondly, an evaluation of women's general satisfaction with induced labor was made, and factors associated with a negative experience...

INTRODUCTION: Misoprostol (Cytotec) was primarily made for treating gastric ulcers. However today it is mostly used for abortion, treating postpartum hemorrhage, and for induction of labor. The tablet contains 200 µg of misoprostol, yet the dosages used for induction of labor are much smaller (25-50 µg), leading to uncertainty of dosage in daily use. AIM: To evaluate and compare the relative bioavailability of two misoprostol products (Angusta 25 µg and Cytotec 200 µg tablets) administered orally or sublingually given in a daily clinical setting to women admitted for induction of labor at term...

OBJECTIVE: To compare the World Health Organization (WHO) recommended orally administrated dosage of misoprostol (25 μg) with a vaginal slow-release (7 μg/hour) insert of misoprostol regarding time from induction to delivery and safety of the method. DESIGN: Open label, Randomised controlled trial (RCT). SETTING: Delivery ward at a secondary referral hospital in Stockholm, Sweden, from 1 October 2016 to 21 February 2018. POPULATION: One hundred and ninety-six primiparous women with singletons in cephalic presentation at ≥37 weeks of gestation and with a Bishop score of ≤4...

OBJECTIVE: Uterine rupture is a well-known but unusual complication in vaginal deliveries with a Cesarean section in the history. The risk of uterine rupture is at least two-fold when labor is induced. In Sweden, women are allowed to deliver vaginally after one previous Cesarean section, regardless if labor starts spontaneously or is induced. The aim of the study is to compare the proportion of uterine ruptures between the three methods (balloon catheter, Minprostin® and Cytotec®) for induction of labor in women with an unfavorable cervix and one previous Cesarean section...

BACKGROUND: Misoprostol vaginal insert for induction of labor has been recently reported to be superior to dinoprostone vaginal insert in a phase III trial, but has never been compared to vaginal misoprostol in another galenic form. The aim of this study was to compare misoprostol vaginal insert (MVI) with misoprostol vaginal tablets (MVT) for induction of labor in term pregnancies. METHODS: In this retrospective cohort study we compared 200 consecutive women induced with 200-μg misoprostol 24-h vaginal insert (Misodel®) with a historical control of 200 women induced with Misoprostol 25-μg vaginal tablets (Cytotec®) every 4-6 h...

Background. Mullerian duct anomalies (MDAs) are congenital defects of the female genital system that arise from abnormal embryological development of the Mullerian ducts. A didelphys uterus, also known as a "double uterus," is one of the least common amongst MDAs. This report discusses a case of didelphys uterus that successfully conceived, carried her pregnancy to term, and delivered vaginally without any significant complications. Case. Patient is a 29-year-old G2P0010 from Bangladesh, initially came a year prior in her first pregnancy, with spontaneous abortion (SAB)...

OBJECTIVE: Serious fetal malformations and/or chromosome aberrations detected by modern diagnostic tools in early pregnancy require discussions on induced abortion with pregnant women. Competent counseling includes prediction of the time needed for the whole abortion process. In an attempt to refine our predictions, we evaluated the impact of 11 medical history and clinical variables on time to delivery. MATERIAL AND METHODS: We performed a retrospective chart analysis on 79 women submitted for pre-term abortion because of fetal anomalies...

BACKGROUND: Misoprostol (Cytotec, Searle) is a prostaglandin E1 analogue widely used for off-label indications such as induction of abortion and of labour. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. OBJECTIVES: To determine the effects of vaginal misoprostol for third trimester cervical ripening or induction of labour. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group's Trials Register (November 2008) and bibliographies of relevant papers...

UNLABELLED: Cytotec (Misoprostol) is a prostaglandin E1 9(PgE1) analogue. Despite that it is not officially registered for obstetric and gynaecological targets, Cytotec (C) is widely used in this sphere. The author aims to study the effect and results from C application used for delivery (birth) induction, as well as means for cervical maturation. In order to reach this aim, beside the group of 45 pregnant women to who we applied C, we also reviewed the existing literature, which reported proves for C efficacy, pharma-kynetics and the safe aspects of its application (usage) in pregnancy...

Misoprostol (Cytotec) is a synthetic prostaglandin E1 analogue that was designed for the prevention and treatment of peptic ulcer associated with the use of nonsteroidal anti-inflammatory drugs. In obstetrics, misoprostol has been administered for induction of first and second trimester abortion, for induction of labor in the third trimester, and to control postpartum hemorrhage. None of these uses has been approved by the Food and Drug Administration. Nevertheless, misoprostol is widely used in the United States and throughout the world...

UNLABELLED: Misoprostol (Cytotec) is a synthetic analogue of PGE1, not yet registered for Obstetric practice. Vowing to its low cost and high efficacy there is marked interest towards this medicament. MATERIALS AND METHODS: 47 patients with induction of labour are distributed into two groups: Gr.A (n = 25), receiving Misoprostol and Gr.B (n = 22) with Oxytocin in perfusion. RESULTS: Protocol of treatment with PGE, includes 50 microg per os every 2 hrs...

The object of this study was to compare the effectiveness of the intravaginal Misoprostol and transcervical Foley catheters as pre-induction cervical ripening agents, to estimate the proportion of patients achieving vaginal delivery and to compare the complications of labour and foetal outcome between the two groups. The study was a prospective, randomised study of pregnant women, with singleton pregnancies who presented for antenatal care and delivery at the University College Hospital (UCH), Ibadan, Nigeria...

Misoprostol (Cytotec) is safe and effective for induction of labor, although it is not approved by the Food and Drug Administration (FDA) for use in pregnancy. In August 2000, the manufacturer of misoprostol warned against its use in pregnancy because of its abortifacient properties and cited reports of maternal and fetal deaths when misoprostol was used to induce labor, fueling the misoprostol controversy. More than 45 randomized trials including more than 5400 women have found vaginal misoprostol to be more effective than oxytocin or vaginal prostaglandin E2 at effecting vaginal delivery within 24 hours...

On April 17, 2002, the U.S. Food and Drug Administration approved a new label for the use of Cytotec (misprostol) during pregnancy. The new labeling does not contain claims regarding the efficacy and/or safety of Cytotec when it is used for cervical ripening for the induction of labor nor does it stipulate doses or dosing intervals. Therefore, the Committee on Obstetric Practice reminds Fellows that this agent should be used as previously recommended.

On April 17, 2002, the U.S. Food and Drug Administration approved a new label for the use of Cytotec (misoprostol) during pregnancy. The new labeling does not contain claims regarding the efficacy and/or safety of Cytotec when it is used for cervical ripening for the induction of labor nor does it stipulate doses or dosing intervals. Therefore, the Committee on Obstetric Practice reminds Fellows that this agent should be used as previously recommended.

OBJECTIVE: The purpose of this study was to compare the relative efficacy and cost of three commercially available prostaglandin analogs, misoprostol (Cytotec), dinoprostone gel (Prepidil), and dinoprostone insert (Cervidil), as labor preinduction agents. STUDY DESIGN: One-hundred eleven women with an unfavorable cervix who underwent labor induction were assigned randomly to receive either misoprostol 50 microg every 6 hours for two doses, dinoprostone gel 0.5 mg every 6 hours for two doses, or dinoprostone insert 10 mg for one dose intravaginally...

BACKGROUND: Misoprostol (Cytotec, Searle) is a prostaglandin E1 analogue marketed for use in the prevention and treatment of peptic ulcer disease. It is inexpensive, easily stored at room temperature and has few systemic side effects. It is rapidly absorbed orally and vaginally. Although not registered for such use, misoprostol has been widely used for obstetric and gynaecological indications, such as induction of abortion and of labour. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology...

No abstract text is available yet for this article.