PubMed Health⌕ Search

Biomedical subjects

F J Roumen

Publications and source records attributed to F J Roumen.

At least 19 recordsLinked to original sources
PubMed2001

[Term breech presentation: an indication for cesarean section].

The results of the 'Term breech trial' (carried out at 121 centres in 26 countries, and in which 2088 women with a singleton foetus in breech presentation were randomly assigned to planned caesarean section or planned vaginal birth) indicate that in countries with low perinatal mortality rates, planned vaginal birth was associated with serious neonatal morbidity at least 12.5 times more often than was the case for planned caesarean section. The trial is methodologically sound. Unfortunately, no information on long-term neonatal morbidity is provided and the study is too small to assess maternal mortality. Moreover, the study provides no information on the consequences of a uterine scar for future pregnancies. However, as there are no other data from studies in the Netherlands, the results from this trial also have a bearing on Dutch practice. The pregnant mother of a term breech baby should be carefully informed about the results of this trial, prior to the preferred means of delivery being decided upon in consultation with her. A deliberate choice for an elective caesarean section based on a mere breech presentation is justified.

Breech Presentation↗
PubMed2001

[More moderate neonatal morbidity in the case of non-randomized vaginal delivery of term breech pregnancies].

OBJECTIVE: To compare the outcome of term breech pregnancies by planned caesarean section or by planned vaginal delivery at the Department of Obstetrics and Gynaecology, Atrium Medisch Centrum Heerlen, the Netherlands, with the findings in the so-called 'Term breech trial' (TBT). DESIGN: Randomised and descriptive non-randomised clinical trial. METHOD: During the period of participation in the TBT prospective data were collected on all deliveries of a term baby in breech presentation. The pregnant women who were included in the TBT (n = 35) were randomised in a planned caesarean section (CS) group and a planned vaginal delivery (VD) group. All women with a child in term breech presentation who did not join the trial constituted the non-randomised group (n = 201) and were divided in a primary CS group (n = 48) and a started VD group (n = 153). Neonatal and maternal mortality and morbidity were analysed according to the intended mode of delivery. RESULTS: Neither neonatal nor maternal mortality occurred in any of the groups. No significant differences in serious neonatal and maternal morbidity were observed between both subgroups in either the randomised or non-randomised group. However, in the non-randomised group who were allowed to start a vaginal delivery, moderate neonatal morbidity was significantly higher (25/153) than in the primary CS group (2/48). CONCLUSION: The differences in serious neonatal morbidity as observed in the TBT were not confirmed in this study. However, there were disadvantageous differences in the moderate neonatal morbidity for the non-randomised group who were allowed to start a vaginal delivery. In addition to the TBT results, these findings might be discussed with women with a term breech presentation.

Adult↗
PubMed2001

Efficacy, tolerability and acceptability of a novel contraceptive vaginal ring releasing etonogestrel and ethinyl oestradiol.

A novel contraceptive vaginal ring releasing etonogestrel 120 microg and ethinyl oestradiol 15 microg daily over a period of 3 weeks was tested. Each ring was used for one cycle, comprising 3 weeks of ring use followed by a 1 week ring-free period. This 1 year, multicentre study assessed the contraceptive efficacy, cycle control, tolerability and acceptability of the contraceptive. Altogether, 1145 women were exposed to the vaginal ring for 12,109 cycles (928 woman-years). Six pregnancies occurred during treatment, giving a Pearl Index of 0.65 (95% confidence interval 0.24--1.41). Cycle control was very good, since irregular bleeding was rare (2.6--6.4% of evaluable cycles) and withdrawal bleeding (mean duration 4.7--5.3 days) occurred in 97.9--99.4% of evaluable cycles. Compliance to the prescribed regimen was high with criteria being fulfilled in 90.8% of cycles. The ring was well tolerated. The majority of women considered this new contraceptive method easy to use, and it offers an effective, convenient, well-accepted and novel method for hormonal contraception.

Cervix Uteri↗
PubMed1999

Clinical acceptability of an ethylene-vinyl-acetate nonmedicated vaginal ring.

In an open study the acceptability of a newly designed vaginal ring was evaluated. The ring being developed for contraceptive purposes was made of ethylene-vinyl-acetate copolymer (EVA). In this study the ring did not contain active medication. Three groups of 20 healthy female volunteers were asked to use rings--with a diameter of 54 mm--for 21 consecutive days; each group was assigned rings with a different cross-sectional thickness of 3, 3.5, or 4 mm. Subjects were given diary cards to report on insertion and removal of the ring and on complaints. Of the 65 women who participated, 59 completed the study and used the ring for at least 21 days, giving an acceptability of 91% (59/65). No major differences were found between the three types of rings except for a sensation of expulsion, which was reported more often in the group assigned the smallest cross-sectional-thickness ring. Expulsion was reported once during intercourse in the 3.5-mm group. Insertion and removal of the rings were judged to be easy by the overall majority of the women. The ring was felt by the partner during intercourse in 35%-50% of couples. Further development of an active combined contraceptive EVA ring with a cross-sectional thickness of 4 mm seems a reasonable option. In future studies with the active ring, allowance for temporary removal of the ring during intercourse, if preferred, may be suggested.

Adolescent↗
PubMed1998

['Labor storm' following cervical ripening with prostaglandin gel].

In three pregnant women aged 26, 31 and 26 years with post-term pregnancy and (or) worsening preeclampsia and an immature cervix, parturition was induced by intracervical application of dinoprostone. This was followed within a few hours by bradycardia of the infants, with a labour frequency of about 5 per 10 minutes and contractions lasting at least 1 minute. After suppression of labour (in two patients, one of whom meanwhile had developed placental detachment), caesarean section was performed without delay. One child by then had sustained major cerebral damage: the other two recovered well. A potentially dangerous adverse effect of intracervical application of prostaglandin gel is excess uterine activity. The higher sensitivity to prostaglandins in several conditions complicating pregnancies (such as serotinicity and preeclampsia), may play a role in this complication. Careful application of the gel, adequate foetal monitoring and using half the normal dose in risk patients could be helpful in preventing foetal distress after intracervical application of prostaglandin gel.

Administration, Topical↗
PubMed1997

[Decreased quality of cervix mucus under the influence of clomiphene: a meta-analysis].

OBJECTIVE: To determine whether clomiphene (citrate) has a negative influence on cervical mucus qualities and whether administration of exogenous oestrogens has a favourable influence in that case. DESIGN: Meta-analysis. SETTING: Stichting Gezondheidszorg Oostelijk Zuid-Limburg, Midwifery School, Kerkrade, the Netherlands. METHOD: Relevant articles were searched using the Medline database for the years 1980-1996 and the Knowledge Finder search system. The reference lists of these articles were studied. All prospective, randomized and controlled clinical trials mentioning detailed figures were selected and analysed. RESULTS: Six articles met all criteria for analysis of the effect of clomiphene on cervical mucus. Clomiphene 50 mg/day had an unfavourable influence on cervical mucus (not significant), but clomiphene 100 and clomiphene 150 mg/day did have a significant effect, the relative risk of unfavourable cervical mucus being more than seven in comparison with women not using clomiphene (respective odds ratios 7.90 (95% confidence interval: 4.15-15.00) and 7.50 (1.97-28.60)). Four articles met all criteria for analysis of the effect of exogenous oestrogens on cervical mucus of women being treated with clomiphene. Exogenous oestrogens resulted in improvement of the cervical mucus qualities in these women (odds ratio: 2.87 (1.76-4.69)). CONCLUSION: The influence of clomiphene 50 mg/day on cervical mucus is not significantly unfavourable, unlike the influence of clomiphene 100 and 150 mg/day. Exogenous oestrogen administration improves this cervical mucus. In all patients being treated with clomiphene the cervical mucus qualities should be investigated.

Cervix Mucus↗
PubMed1996

The cervico-vaginal epithelium during 20 cycles' use of a combined contraceptive vaginal ring.

The aim of the study was to evaluate the influence of a combined contraceptive vaginal ring (CCVR) made of Silastic on the cervico-vaginal epithelium during 20 cycles of use. A total of 76 volunteers used the CCVR releasing 0.120 mg etonogestrel and 0.015 mg ethinyloestradiol daily. Cytological samples were taken of the vaginal epithelium, the ectocervix and the endocervix before the start, at 4 and 12 months, and at the end of the study. Cytology, hormonal profiles, human papilloma virus (HPV) status, DNA-flow cytometry, bacterial flora, and morphometry was performed on these samples. Colposcopy and histopathology of biopsy specimens were performed at the end. No cytological changes of the squamous epithelium or the columnar epithelium were found. HPV was detected in three samples of three different women. At least two of them reverted to HPV negative during the rest of the study period. Aneuploidy was diagnosed in 11 women before the study. Seven of them changed to diploid during the study. No changes from diploid to aneuploid were seen. Aneuploidy was not seen in any of the HPV positive samples. Although bacterial flora showed considerable variation during the study, no significant influence of the CCVR could be established. Morphometrical analysis showed an increasing nucleus:cytoplasm ratio of the squamous cells during the study. Mild dysplasia was detected in one woman at the end of the study. It was concluded that no unfavourable cytological or bacteriological changes of the cervico-vaginal epithelium were demonstrated during 20 cycles of CCVR use. The vaginal epithelium became more progestogenic during the study.

Aneuploidy↗
PubMed1995

The essential fatty acid status of mother and child in pregnancy-induced hypertension: a prospective longitudinal study.

OBJECTIVE: Our purpose was to investigate, in a prospective way, whether the altered essential fatty acid status observed in pregnancy-induced hypertension is a consequence of the disease or may contribute to its cause. STUDY DESIGN: Pregnant women healthy at the start of the study were asked to give a blood sample before 16 weeks, at 22 weeks, and at 32 weeks of gestation. After delivery a blood sample from the umbilical vein, a piece of the umbilical cord, and a maternal blood sample were collected. Fatty acid compositions were determined of the phospholipids isolated from plasma and umbilical arterial and venous vessel walls. The nutrient intake of the pregnant women was assessed by use of the dietary history method and food frequency questionnaires. The results of each woman with pregnancy-induced hypertension were compared with the results of three matched healthy controls. RESULTS: During pregnancy (16 to 32 weeks) no significant differences were observed in nutrient intake and maternal plasma fatty acid composition between the group with pregnancy-induced hypertension (n = 52) and the control group (n = 156). After delivery the relative amounts of 18:2(n-6) and 18:3(n-3) in maternal plasma were significantly lower in pregnancy-induced hypertension than in normal pregnancy. This was associated with significantly higher levels of (n-6) long-chain polyenes and cervonic acid (22:6[n-3]). In comparison with the situation at 32 weeks, the postpartum cervonic acid status increased in pregnancy-induced hypertension, whereas it decreased in normal pregnancy. The cervonic acid levels in umbilical plasma phospholipids were significantly higher after pregnancy-induced hypertension than after normal pregnancy. No significant differences were observed for the fatty acid content in umbilical vessel walls. CONCLUSION: The results indicate that the altered essential fatty acid status in pregnancy-induced hypertension is a late phenomenon and is therefore unlikely to have contributed to the pathogenesis of pregnancy-induced hypertension. Moreover, the neonatal essential fatty acid status is not negatively affected by pregnancy-induced hypertension.

Adult↗
PubMed1994

Human parvovirus B19 infection and unbalanced translocation in a case of hydrops fetalis.

In a case of hydrops fetalis, serological examination showed a recent maternal human parvovirus B19 infection. Amniocentesis revealed a unique unbalanced translocation between chromosomes 3 and 11 of the fetus. The mother proved to have a balanced reciprocal translocation between chromosomes 3 and 11. A grossly macerated hydropic male fetus was delivered with a flat nose and low implanted deformed ears. Histopathological examination revealed nuclear inclusion bodies in fetal erythroid cells, confirming human parvovirus B19 infection. Parvovirus B19 DNA was demonstrated by in situ hybridization in the nuclei of heart muscle cells. Our finding of two different disorders in one case illustrates the importance of a complete evaluation of every case of hydrops fetalis, especially concerning counselling on the outcome of future pregnancies. The human parvovirus B19 infection will not recur due to the acquired immunity of the mother, whereas the balanced reciprocal translocation will endanger future pregnancies.

Adult↗
PubMed1993

Achievement of therapeutic concentrations of cefuroxime in early preterm gestations with premature rupture of the membranes.

OBJECTIVE: To determine whether therapeutic cefuroxime concentrations can be achieved in maternal plasma, amniotic fluid (AF), neonatal plasma, placenta, and membranes in women with premature rupture of the membranes (PROM) at 27-33 weeks' gestation. METHODS: In an open nonrandomized, dose-response study, nine patients with PROM at 27-33 weeks' gestation received 1.5 g of cefuroxime intravenously three times daily. Maternal plasma and AF specimens were collected during pregnancy, and umbilical cord plasma, placenta, and membrane specimens were collected after delivery to assay cefuroxime concentrations using high-performance liquid chromatography. RESULTS: A high rate of placental transfer of cefuroxime was found. Bactericidal concentrations could be demonstrated in maternal plasma and in AF leaking from the vagina. A concentration-time curve in AF could be detected, with a peak concentration 3-4 hours after infusion. Therapeutically active levels were present in the newborns. The resorption of cefuroxime by the fetal membranes was high. CONCLUSIONS: Therapeutic concentrations of cefuroxime were found in all body fluids and tissues studied. Further study to establish the clinical utility of cefuroxime prophylaxis in PROM seems appropriate.

Adult↗
PubMed1992

Serum osteocalcin as a marker for vitamin K-status in pregnant women and their newborn babies.

Osteocalcin (bone Gla-protein) is a vitamin K-dependent protein synthesized by osteoblasts. Its hydroxylapatite binding capacity (HBC) is generally used to estimate the Gla-content of circulating osteocalcin. Here we have used the HBC of serum osteocalcin as a marker for the vitamin K-status in pregnant women and their offspring. For all cases investigated the HBC values in the cord samples were substantially lower than in the corresponding maternal ones. Babies from mothers who had been treated with vitamin K during the last 6 weeks prior to delivery, had significantly higher HBC values than those from a placebo group. The results presented in this paper are indicative for a generally occurring vitamin K deficiency in newborns. At delivery the HBC in untreated women was low as well. In both the placebo- and the vitamin K-group a good correlation was found between the HBC values in paired samples from mother and child. Whether the maternal HBC value may be used as a prenatal marker for estimating the fetal vitamin K-status remains to be seen.

Adsorption↗
PubMed1992

Prenatal ultrasound diagnosis of an intracranial teratoma influencing management: case report and review of the literature.

Of seventeen cases of prenatally diagnosed intracranial teratomas, fourteen babies were delivered through a cesarean section. All children died before or shortly after delivery. In this report another case is presented of ultrasound diagnosis of an intracranial teratoma. The teratoma filled the whole fetal cranium, and eroded through the skull base into the left maxillary region. In full agreement with the wishes of the parents, conservative management resulted in the spontaneous vaginal delivery of a fetus that died during labor as a result of brain compression and acidosis during the second stage. In contrast with other cases in the literature, no encephalocentesis was performed. In order to minimize maternal morbidity, it is advised to induce or accept labor as soon as the diagnosis is clear and to pursue a vaginal delivery.

Adult↗
PubMed1992

[Post-asphyctic encephalopathy of the neonate following administration of nalbuphine during childbirth].

After an intramuscular injection of nalbuphine during parturition a foetal bradycardia of 30-40 beats/minute developed, which normalised after an intravenous maternal injection of naloxone. Because the cardiotocography did not show variability after the event, a caesarean section was performed. Six months later the child still had a severe neurological disorder which was attributed to intrauterine asphyxia. Several authors published reports in which no relevant clinical problems were described after nalbuphine given during labour. Recently, however, four children have been described with bradycardia and respiratory depression after maternal intravenous and/or intramuscular injection of nalbuphine. Apparently, the use of nalbuphine during labour can cause foetal bradycardia, both after intravenous and after intramuscular administration. Great reserve is advised regarding use of nalbuphine for this indication. The antidote naloxone should be within reach.

Adult↗
PubMed1991

Safety of term vaginal breech delivery.

Of 247 women who were pregnant of one healthy child in breech presentation at term, 13 (5.3%) were delivered by a primary cesarean section. The other 234 (94.7%) were allowed to attempt vaginal birth. In these women, the only factor to determine the possibility of a vaginal delivery was normal progression of labor during the first stage, without secondary arrest or signs of fetal distress. 109 Women (44.1%) were delivered spontaneously according to Bracht, 87 (35.2%) had an assisted breech delivery, and 38 (15.4%) underwent a secondary cesarean section. There were two perinatal deaths (0.8%). One of them was directly related to the trial of labor. Two children with a birth trauma had an uneventful recovery. The 1 min Apgar score in all breech delivery groups was more often lower than in a control group of children, who were born spontaneously at term in vertex presentation. However, the 5 min Apgar score and the mean umbilical artery pH were within normal limits in all groups. The secondary cesarean section rate was inversely related to vaginal parity of the mother, and directly related to the newborns' birth weight. There was no relation between the secondary cesarean section rate and the type of breech presentation. It is concluded, that a trial of labor in carefully selected patients with a child in breech presentation at term is a safe procedure, that can be successfully completed in almost 80% of cases. In retrospect, low vaginal parity and high birth weight of the newborn have a negative influence on normal progression of labor.

Adult↗
PubMed1990

Pharmacokinetics of cefuroxime in pregnant patients with preterm premature rupture of the membranes.

To 6 pregnant patients with preterm premature rupture of the membranes, cefuroxime prophylaxis was given 1,500 mg three times daily intravenously. Cefuroxime concentrations were assayed in maternal plasma and amniotic fluid during pregnancy and in umbilical cord blood, placenta, and membranes after delivery. Our results showed a high rate of transplacental transfer of cefuroxime. Bactericidal levels could be demonstrated in maternal plasma, and in amniotic fluid leaking from the vagina. Therapeutically active levels were present in the newborns. The absorption of cefuroxime by the foetal membranes was high. Although the neonatal morbidity in this high-risk population was low, the data are still too preliminary to advise the routine prophylactic use of cefuroxime to pregnant patients with preterm premature rupture of the membranes.

Adult↗
PubMed1990

Non-Hodgkin lymphoma of the puerperal uterus.

Non-Hodgkin lymphoma was diagnosed initially in a curettage specimen of a puerperal uterus 3 weeks after normal delivery of a healthy infant. The disease, which probably existed during the last trimester of pregnancy, was classified as clinical stage IVb. Combination chemotherapy resulted in immediate improvement and complete remission after several months. Histopathologic examination of the uterus 10 months after starting therapy demonstrated complete disappearance of the malignant lymphoma.

Adult↗
PubMed1989

[Outcome of delivery following previous cesarean section].

Of 249 women whose last pregnancy was terminated by a caesarean section, 57 (22.9%) were delivered again by a primary caesarean section. The other 192 (77.1%) were allowed to attempt vaginal birth. Of these, 151 (60.6%) were successful, and 41 (16.5%) underwent a repeat caesarean section. The percentage of successful vaginal births was strongly correlated with the indication for the previous caesarean section. There was one case of incomplete uterine rupture. The maternal morbidity was lowest in the group who had a vaginal delivery. One child developed an Erb-Duchenne paralysis in addition to a mechanical birth trauma. In the secondary caesarean section group there were more children with a low one minute Apgar score than in the group delivered vaginally or by a primary caesarean section. It is concluded that there are sufficient arguments against routinely performing a repeat caesarean section after a previous one. The indication for the previous caesarean section can be an important aid in the selection of women to be allowed to try a vaginal delivery.

Adult↗