Self-administered multi-level pregnancy tests in simplified follow-up of medical abortion in Tunisia.

BACKGROUND: This study was conducted to assess the efficacy and acceptability of using a multi-level pregnancy test (MLPT) combined with telephone follow-up for medical abortion in Tunisia, where the majority of providers are midwives. METHODS: Four hundred and four women with gestational age ≤ 70 days' LMP seeking medical abortion at six study sites were enrolled in this open-label trial. Participants administered a baseline MLPT at the clinic prior to mifepristone administration and were asked to take a second MLPT at home and to call in its results before returning the day of their scheduled follow-up visit 10-14 days later. RESULTS: Almost all women with follow-up (97.1 %, n = 332/342) had successful abortions without the need for surgical intervention. The MLPT worked extremely well among women ≤63 days' LMP in ruling out ongoing pregnancy (negative predictive value (NPV) =100 % (n = 298/298)) and also detecting women with ongoing pregnancies (sensitivity = 100 %; 2/2) as needing follow-up due to non-declining hCG. Among women 64-70 days' LMP, the test also worked well in ruling out ongoing pregnancy (NPV = 96.9 % (n = 31/32) but not as well in terms of sensitivity (50 %), with only one of two ongoing pregnancies detected by MLPT as needing follow-up. Most women (95.1 %) found the MLPT to be very easy or easy to use and would consider using the MLPT again (97.4 %) if needed. CONCLUSIONS: Self-administered pre and post MLPT are very easy for women to use and accurate in assessing medical abortion success up to 63 days' LMP. MLPT use for medical abortion follow-up has the potential to facilitate task sharing services and eliminate the burden of routine in-person follow-up visits for the large majority of women. Additional research is warranted to explore the accuracy of the MLPT in identifying ongoing pregnancy among women with gestational ages > 63 days. TRIAL REGISTRATION: This study was registered on May 13, 2010, on clinicaltrials.gov as NCT01150279 .

A double-blind randomized controlled trial of mifepristone or placebo before buccal misoprostol for abortion at 14-21 weeks of pregnancy.

OBJECTIVE: To assess differences in outcomes of misoprostol with or without mifepristone for second-trimester abortion. METHODS: A randomized, double-blind, placebo-controlled trial of buccal misoprostol following placebo or 200mg mifepristone was done in Tunisia among women presenting for abortions at 14-21 weeks of pregnancy between August 2009 and December 2011. Women with a live fetus, a closed cervical os, no cervical bleeding, and no contraindications to study drugs were eligible and underwent randomization (block size 10). Participants returned 24 hours later to receive 400 µg buccal misoprostol every 3 hours until complete fetal and placental expulsion (maximum 10 doses, five per 24-hour period). The primary outcomes were rates of complete uterine evacuation at 48 hours and time to expulsion. RESULTS: A total of 120 women were evenly randomized to treatment. Complete uterine evacuation at 48 hours was recorded in 55 (91.7%) women in the combined group versus 43 (71.7%) in the misoprostol alone group (relative risk 1.28; 95% confidence interval 1.07-1.53). Mean time to complete abortion was 10.4±6.6 hours in the group who received mifepristone versus 20.6±9.7 hours in the misoprostol alone group (P<0.001). Side effects were similar in both groups. CONCLUSION: Adding mifepristone before misoprostol can improve the quality of second-trimester abortion care by making the process faster.

A two-pill sublingual misoprostol outpatient regimen following mifepristone for medical abortion through 70 days' LMP: a prospective comparative open-label trial.

OBJECTIVE: To test the effectiveness and acceptability of an outpatient medical abortion protocol with 200 mg mifepristone and 400 mcg sublingual misoprostol at 64-70 days' last menstrual period (LMP) and compare it to the already known efficacy of the 57-63 days' LMP gestational age range. STUDY DESIGN: We conducted a prospective, comparative open-label trial in six hospitals and clinics in Ukraine, Georgia, India and Tunisia. We enrolled 714 reproductive age women with pregnancies 57 to 70 days who presented requesting abortion. Medical abortions were managed with the current service delivery protocol (200 mg oral mifepristone followed in 24-48 h by 400 mcg sublingual misoprostol). Data on safety, efficacy and acceptability were collected. The main outcome measure was complete abortion without surgical intervention at any point. RESULTS: A total of 703 cases were analyzable for efficacy. Success rates did not differ significantly in the two groups [57-63-day group: 94·8%; 64-70-day group: 91.9%; Relative Risk (RR): 0.79 (0.61-1.04)]. Ongoing pregnancy rates also did not differ significantly (57-63 days: 1.8%; 64-70 days: 2.2%; RR: 1.10 (0.65-1.87)]. CONCLUSION: A medical abortion regimen of 200 mg mifepristone followed in 24-48 h by 400 mcg sublingual misoprostol is effective through 70 days' gestation and may be offered within existing outpatient abortion services. IMPLICATIONS: A regimen of 200 mg mifepristone followed in 24-48 h by 400 mcg sublingual misoprostol is effective up to 70 days' LMP. The findings have important implications for expanding access to outpatient medical abortion services in settings where the cost of misoprostol is of concern or a two-pill misoprostol regimen is the standard of care.

[Evaluation of different techniques for vaginoplasty in the treatment of Mayer-Rokitansky-Kuster-Hauser syndrome]. / Evaluation des différentes techniques de vaginoplastie dans le cadre du traitment du syndrome de Mayer-Rokitansky-Küster-Hauser.

BACKGROUND: Rokitansky syndrome is an utero-vaginal aplasia with a frequency of 1 / 5000 female births. To correct this anomaly whose prognosis is mainly functional and psychological numerous surgical techniques have been described. AIMS: To report our experience about 13 patients with Rokitansky syndrome and having benefited from a vaginoplasty between 1993 and 2008 and to evaluate the results of the various anatomical techniques. METHODS: This is a retrospective study of 13 patients who underwent a vaginoplasty in the center of maternity and neonatal units, over a period from December 1993 to April 2008. During this period, two operative techniques were used: the technique of Mac-Indoe and the technique of Davydov. RESULTS: The mean age at the time of surgery was 22 years (15 years-32 years). In 6 patients operated using the technique of Davydov the average depth of neovagina was 6.83 cm, one treatment failure was noted. Among the 7 patients operated using the technique of Mac Indoe the average length of neovagina was 7 cm, 3 treatment failures were noted. It was noted that there was no failure of the anatomical results in patients who have had regular sex after surgery. It was noted that there was failure of the anatomical result in 4 of 9 patients who did not have sexual intercourse after the procedure regardless of the technique used, a failure rate of 44%. CONCLUSION: The choice of technique will be based on the experience of the teams as each technique has similar anatomical and functional results in the literature. Both anatomical and functional, the main factor that determines the success of treatment seems to be the motivation of the patient to have a married life and sexual relationship.

Comparison of misoprostol-only and combined mifepristone-misoprostol regimens for home-based early medical abortion in Tunisia and Vietnam.

OBJECTIVE: To assess the potential advantages of combined mifepristone-misoprostol versus misoprostol-only for early medical abortion. METHODS: A double-blind randomized placebo controlled study was conducted that enrolled 441 pregnant women (<63 days since last menstrual period) at 2 hospitals in Tunisia and Vietnam. The mifepristone-misoprostol group (n=220) received 200mg of mifepristone on day 1 and 800 µg buccal misoprostol followed by placebo 3 hours later on day 2. The misoprostol-only group (n=221) received placebo on day 1 and 1600 µg of misoprostol (2 doses of 800 µg, given 3 hours apart) on day 2. All medications were self-administered at home with follow-up 1 week later. The primary outcome was complete uterine evacuation without surgical intervention. RESULTS: Successful uterine evacuation occurred for 78.0% (n=170) of women with misoprostol only versus 92.9% (n=195) of women with mifepristone-misoprostol (relative risk 0.84, 95% CI, 0.78-0.91; P<0.001). Ongoing pregnancy occurred for 13.8% (n=30) of women given misoprostol-only and 1.4% (n=3) of women given mifepristone-misoprostol (relative risk 9.63, 95% CI 2.98-31.09; P<0.001). CONCLUSION: Mifepristone plus misoprostol is significantly more effective than misoprostol-only for early medical abortion.

Reduced maternal mortality in Tunisia and voluntary commitment to gender-related concerns.

OBJECTIVE: To estimate the number and causes of maternal deaths in Tunisia from 1999 to 2007, and compare the results with the last report (1993-1994). METHODS: Data on all deaths of women of reproductive age in the public (1999-2007) and private (2006 only) health sectors were collected and assessed for whether the death was due to pregnancy. Number of live births was provided by the National Institute of Statistics. RESULTS: Mean maternal mortality ratio (MMR) in Tunisia decreased from 68.9 per 100000 live births in 1993-1994 to 36.3 (95% confidence interval, 27.9-46.5) in 2005-2007 (P<0.001). Causes of maternal death did not change significantly during the study period (1999-2007): hemorrhage and hypertensive disorders were the main causes. The gap between urbanized and more rural regions observed in 1993-1994 had narrowed, although MMR remained higher in central and western regions than on the east coast. CONCLUSION: The improvement in MMR can be credited to the voluntary political commitment focused on gender-related concerns that has been made in Tunisia, including access to family planning; legalization of abortion; and creation of the National Board for Family and Population, and the Tunisian Safe Motherhood initiative in 1999.

[Obstetric vesicovaginal fistulas, about 131 cases]. / Les Fistules Vésico-Vaginales D'origine Obstétricale. A propos de 131 cas.

BACKGROUND: Vesicovaginal fistulas are the most frequent type of urogenital fistulas. Obstetrical cause remains the dominant etiology. They still represent a public health problem. Aim : to study epidemiological aspects of obstetric vesico-vaginal fistulas and their management. METHODS: a retrospective multicentric study among 19 hospital departments from February 1982 to January 2007. RESULTS: 131 VVF (92% of urogenital fistulas). The vaginal route for surgical repair was used in 2/3 cases. The mean diameter of the fistula was 11.35 mm. In 122 cases (86.5%), the fistula was unique. IVU findings were normal in 83% cases. All patients had normal renal function apart one who had acute renal failure. 177 interventions were performed (1.37 intervention per patient). CONCLUSION: Our findings suggest a regression in obstetrical VVF. However many efforts on institutional, socioeconomic and obstetrical levels have to be done in order to eradicate this pathology that is of major handicap for women regarding socioeconomic, functional and psychological effects.

Fetal sex assignment by first trimester ultrasound: a Tunisian experience.

OBJECTIVE: To assess the feasibility and accuracy of fetal sex identification during the first trimester ultrasound exam. METHODS: A prospective study was carried out on 312 fetuses at 11-14 weeks' gestation. The genital region was examined by transabdominal ultrasound. The angle of the genital tubercle to a horizontal line through the lumbosacral skin was measured. Fetal gender was assigned as male if this angle was > 30 degrees and female when it was < 10 degrees . RESULTS: Sex assignment was feasible in 89.7% and accurate in 85.7% of fetuses. Accuracy was similar in males as in females (87.9% vs 83.3%; NS). However, accuracy increased significantly during the gestational age period in male (Chi-square for trend P = 0.03) but not in female (P = 0.41) fetuses. Compared with singletons, presence of multiple fetuses (n = 12) did not influence feasibility or accuracy (89.2% vs 96% and 85.6% vs 86.4% respectively). In male fetuses, there was a significant increase in the angle of the genital tubercle with increasing crown-rump length(CRL) (r = 0.667; p = 0.025), while in females the angle did not significantly change with increasing gestation. CONCLUSION: Sonographic first trimester sex assignment is highly feasible and accurate.

[Early diagnosis and management of cervical ectopic pregnancy]. / Diagnostic precoce et prise en charge des grossesses cervicales.

BACKGROUND: Cervical pregnancy is the rarest of ectopic pregnancy. The classical treatment remains hysterectomy, in particular when diagnosis is made late. The possibilities of more and more premature diagnoses, sometimes before any clinical expression, let suspect the possibility of conservative treatments. We report two cases of medical treatment for early diagnosed cervical pregnancies. AIM: Through a review of the literature, we resume diagnostic criteria and various therapeutic possibilities. CASE REPORTS: The two cases were diagnosed in the first trimester. The treatment consisted in intramuscular administration of methotrexate. The first patient had ultrasound-Guided feticide before the administration of methotrexate. CONCLUSION: Actually, vaginal ultrasound allows early diagnosis of cervical pregnancies, even before the beginning of vaginal bleeding. This advancement allowed conservative treatment. In this situation, current reference is the methotrexate to which can be associated an intracardiac potassium chloride injection in case of embryo positive heart activity.

[Ovarian pregnancy. Report of three cases]. / Grossesse ovarienne, à propos de 3 cas.

BACKGROUND: Ovarian pregnancy is a rare type of ectopic pregnancy. Its diagnosis and management are often difficult. AIM: To highlight specific diagnostic and therapeutic properties of ovarian pregnancy. METHODS: Retrospective Study over a period of 4 years. We observed the patients presenting ovarian pregnancies. Diagnosis was evocated in time of surgery and confirmed by histological data. RESULTS: We observed three patients presenting ovarian pregnancies. All our patients had an abdominal ache. Diagnosis was made by ultrasound scan examination in one case. One patient had a laparotomy as a matter of urgency; the two others had a laparoscopy. All the patients were managed conservatively. The diagnosis of ovarian pregnancies was evocated in time of surgery and confirmed by the histological data. CONCLUSION: the ovary is a rare location for extra-uterine pregnancy. This type of ectopic pregnancy has some clinical properties. The diagnosis is intricate and based on per operatory observations. The management is in spite of medicines improvement, based on surgery.

[First trimester ultrasound: an early screening tool for fetal structural and chromosomal abnormalities]. / Echographie du premier trimestre: un outil de dépistage précoce des malformations foetales et des anomalies chromosomiques.

BACKGROUND: Prenatal diagnosis has been greatly expanded in recent years. Many biological and sonographic criteria participated in the development of fetal medicine. AIM: Analyze the contribution of first trimester ultrasound in prenatal diagnosis of aneuploidy and early fetal malformations, and its impact on the strategy of prevention of disability. METHODS: A prospective longitudinal descriptive study including all women who did a first trimester ultrasound during their pregnancy. We evaluated the detection rate of malformations and chromosomal abnormalities of the morphological embryonary study and nuchal translucency. These tests were then confronted with the results of fetal samples and the outcome of pregnancy. RESULTS: 593 ultrasound examinations were performed. The average age of pregnant women was 32.7 years. The mini-morphological ultrasound study revealed 26 abnormalities (3 major lethal malformations, 5 cystic hygroma and 18 increased nuchal translucency). Chromosomal abnormalities were found in six cases. The first trimester ultrasound has ensured the detection of 2/3 of total aneuploidies of the study. CONCLUSION: The first trimester ultrasound allows early detection of a large number of aneuploidies and fetal malformations.

Extralobar pulmonary sequestration revealed by prenatal hydrothorax.

BACKGROUND: Pulmonary sequestration is a rare congenital pulmonary anomaly that can be diagnosed in utero. AIM: Report a New case. CASE REPORT: In this case report of extralobar pulmonary sequestration, the authors report a case revealed by hydrothorax and describe this disease appearance in different imaging technique (Doppler ultrasonography, magnetic resonance imaging and postnatal multislice CT angiography).

Prenatal diagnosis of ectopia cordis: case report.

UNLABELLED: Ectopia cordis is a rare and impressive malformation presenting as an isolated lesion or as part of the Cantrell's pentology syndrom. It is defined as an anomaly in which the fetal heart lies outside the thoracic cavity. THE AIM of the study is to report the prenatal diagnostic features and management of ectopia cordis. CASE REPORT: We report a prenatal diagnosis case of ectopia cordis using two-dimensional ultrasound at 19 weeks of gestation. Multiple congenital anomalies were found. The most important one was the presence of a ventral thoracoabdominal wall defect with exstrophy of the heart, liver, stomach and intestines. Histopathological examination confirmed the ultrasound findings. Due to severity of the malformations, termination of pregnancy was made.

[Eclampsia: epidemiological aspects and management of 28 patients]. / Eclampsie: profil épidémiologique et prise en charge a propos de 28 cas.

AIM: To ascertain the characteristics, clinical features, and maternal fetal outcome in eclampsia in a tertiary referral center (Service A, CMNT). METHODS: 28 case notes were retrieved retrospectively and data was analyzed descriptively. RESULTS: Twenty eight pregnancies complicated by eclampsia were identified. 14.8% of the women were nulliparous and 50% were primiparous. The mean age was 32.5 years. Mean gestational age at the time of seizures was 33.4 weeks' gestation. Twenty-two women had antepartum seizures (78.57%); 8 of the 22 had seizures at home. 6 women had postpartum seizures (21.42%). Headache preceded seizures in 17 cases (60%) hyperreflexia preceded seizures in 16 cases. 50% of women presented with systolic blood pressure (SBP) > 160 mmHg and 42.85% presented with diastolic blood pressure (DBP) > 110 mmHg. One case of maternal mortality are noted. There were 12 perinatal deaths. Three patients had intrauterine fetal deaths. CONCLUSION: Eclampsia increased maternal and perinatal morbidity and mortality. She was not found to be a progression from severe preeclampsia. There is a need to develop new methods to identify this group of patients in an effort to further reduce the prevalence of this dangerous condition.

[Prenatal ultrasound aspects of arthrogryposis multiplex congenita]. / Aspects echographiques de l'arthrogrypose congenitale multiple.

AIM: To analyze the contribution of prenatal ultrasound in the diagnosis of arthrogryposis multiplex congenital according to its type and antenatal expression. METHODS: Retrospective study led between January 1993 and November 2007. We studied the cases of arthrogryposis suspected or diagnosed by antenatal ultrasound while analyzing the circumstances of discovery, the profile of the pregnant women and the abnormal scan findings. RESULTS: 16 observations have been collected. We recovered one multiple pterigium syndrome and five observations of severe fetal akinesia sequences diagnosed in the second trimester. The arthrogryposis was part of different syndromes in other cases. Four distal arthrogryposis had been diagnosed in the second trimester. All cases suspected during the third trimester were associated to an anomaly of the amniotic fluid, mainly to a polyhydramnios. The abnormal scan findings were less specific to this term. CONCLUSION: Arthrogryposis multiplex congenital is rare. It has several morphological aspects. Some ultrasound aspects are specific in the first and second trimesters. The diagnosis is more difficult at the third trimester.