Placental cord drainage in the third stage of labor: Randomized clinical trial.
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ABSTRACT:
SUBMITTER: Vasconcelos FB
PROVIDER: S-EPMC5931461 | biostudies-literature | 2018
REPOSITORIES: biostudies-literature
Publications
Placental cord drainage in the third stage of labor: Randomized clinical trial.
Vasconcelos Fernanda Barros FB Katz Leila L Coutinho Isabela I Lins Vanessa Laranjeiras VL de Amorim Melania Maria MM
PloS one 20180502 5
<h4>Methods</h4>An open randomized clinical trial was developed at Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) in Recife and at Petronila Campos Municipal Hospital in São Lourenço da Mata, both in Pernambuco, northeastern Brazil, including 226 low-risk pregnant women bearing a single, full-term, live fetus after delayed cord clamping, 113 randomized to placental cord drainage and 113 to a control group not submitted to this procedure. Women incapable of understanding the study ...[more]
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Project description:Observational studies have demonstrated that placental cord drainage can shorten the length of the third stage of labour and reduce blood loss during vaginal deliveries. The aim of our work was to evaluate the existing evidence for the effectiveness of placental cord drainage in the third stage of labour. PubMed, Embase, the Cochrane Library, Web of Science, Google Scholar and 50 journals were searched up to the 4th of June, 2017. Randomized controlled trials comparing placental cord drainage with no cord drainage in the third stage of labour during vaginal delivery were included. Nine studies with 2653 participants were included. Compared with clamping the umbilical cord, umbilical cord drainage during the third stage of labour shortened the third-stage duration by 2.28 minutes (95% confidence interval (CI), -3.22 to -1.33), but did not reduce the amount of blood loss (-31.99 mL, -86.08 to 22.09). For women with normal vaginal deliveries, the incidence of postpartum haemorrhage was reduced by 3%. Placental cord drainage is a simple and non-invasive procedure that should be considered after delayed cord clamping. Further studies about the physiological processes and effects of placental cord drainage in additional circumstances are needed.
| S-EPMC5539148 | biostudies-literature
Project description:IntroductionOpioids are used for pain relief during the first stage of labor. Oxycodone can cause maternal hypotension that may modify utero- and fetoplacental circulatory physiology. We hypothesized that maternal intravenous (i.v.) oxycodone has no detrimental effect on utero- and fetoplacental hemodynamics during the early first stage of labor.Material and methodsTwenty-two parturients requiring pain relief during the first stage of labor were randomized in a double-blinded and placebo-controlled study. By Doppler ultrasonography, both uterine artery (Ut) and umbilical vein (UV) volume blood flows (Q), Ut pulsatility index (PI), and Ut vascular resistance (RUt) were calculated. Blood flow velocity waveforms were obtained between uterine contractions. After baseline measurements, women received oxycodone 0.05 mg/kg or a placebo intravenous. Doppler ultrasonography was repeated up to 120 min after the first drug administration. The second dose of oxycodone 0.05 mg/kg was allowed at 60 min to all parturients with contraction pain ≥5/10. Maternal plasma samples were collected at each study phase and after delivery with umbilical cord plasma samples, to measure oxycodone concentrations.Clinicaltrialsgov identifier (NCT no. NCT02573831).ResultsAt baseline, mean QUt and QUV did not differ significantly between the placebo-first (478 mL/min and 57 mL/min/kg) and the oxycodone-first (561 mL/min and 71 mL/min/kg) groups. In addition, RUt and Ut PI were comparable between the groups. Following oxycodone at 60 min, mean QUt and QUV (714 mL/min and 52 mL/min/kg) were similar to the placebo-first (520 mL/min and 55 mL/min/kg) group. Furthermore, all the measured parameters were comparable to the baseline values. At 60 min after the first study drug administration, all the parturients in the placebo-first group needed intravenous oxycodone 0.05 mg/kg. At 120 min, we found no statistically significant change in any of the measured parameters. No significant correlation was found between maternal oxycodone concentration and QUt or QUV. Furthermore, newborn oxycodone concentration did not correlate with QUV.ConclusionsOxycodone did not have any detrimental effect on either utero- or fetoplacental circulatory physiology during the early first stage of labor. Maternal plasma oxycodone did not correlate with utero- and fetoplacental hemodynamics. No correlation was found between newborn oxycodone concentration and fetoplacental hemodynamics.
| S-EPMC10378015 | biostudies-literature
Project description:BackgroundOxytocin for postpartum hemorrhage (PPH) prophylaxis is commonly administered by either intramuscular (IM) injection or intravenous (IV) infusion with both routes recommended equally and little discussion of potential differences between the two. This trial assesses the effectiveness and safety of 10 IU oxytocin administered as IM injection versus IV infusion and IV bolus during the third stage of labor for PPH prophylaxis.MethodsIn two tertiary level Egyptian maternity hospitals, women delivering vaginally without exposure to pre-delivery uterotonics were randomized to one of three prophylactic oxytocin administration groups after delivery of the baby. Blood loss was measured 1 h after delivery, and side effects were recorded. Primary outcomes were mean postpartum blood loss and proportion of women with postpartum blood loss ≥500 ml in this open-label, three-arm, parallel, randomized controlled trial.ResultsFour thousand nine hundred thirteen eligible, consenting women were randomized. Compared to IM injection, mean blood loss was 5.9% less in the IV infusion arm (95% CI: -8.5, - 3.3) and 11.1% less in the IV bolus arm (95% CI: -14.7, - 7.8). Risk of postpartum blood loss ≥500 ml in the IV infusion arm was significantly less compared to IM injection (0.8% vs. 1.5%, RR = 0.50, 95% CI: 0.27, 0.91). No side effects were reported in any arm.ConclusionsIntravenous oxytocin is more effective than intramuscular injection for the prevention of PPH in the third stage of labor. Oxytocin delivered by IV bolus presents no safety concerns after vaginal delivery and should be considered a safe option for PPH prophylaxis.Trial registrationclinicaltrials.gov # NCT01914419 , posted August 2, 2013.
| S-EPMC6339323 | biostudies-literature
Project description:ObjectivesSpontaneous preterm labor is an obstetrical syndrome accounting for approximately 65-70% of preterm births, the latter being the most frequent cause of neonatal death and the second most frequent cause of death in children less than five years of age worldwide. The purpose of this study was to determine and compare to uncomplicated pregnancies (1) the frequency of placental disorders of villous maturation in spontaneous preterm labor; (2) the frequency of other placental morphologic characteristics associated with the preterm labor syndrome; and (3) the distribution of these lesions according to gestational age at delivery and their severity.MethodsA case-control study of singleton pregnant women was conducted that included (1) uncomplicated pregnancies (controls, n=944) and (2) pregnancies with spontaneous preterm labor (cases, n=438). All placentas underwent histopathologic examination. Patients with chronic maternal diseases (e.g., chronic hypertension, diabetes mellitus, renal disease, thyroid disease, asthma, autoimmune disease, and coagulopathies), fetal malformations, chromosomal abnormalities, multifetal gestation, preeclampsia, eclampsia, preterm prelabor rupture of the fetal membranes, gestational hypertension, gestational diabetes mellitus, and HELLP (hemolysis, elevated liver enzymes and low platelet count) syndrome were excluded from the study.ResultsCompared to the controls, the most prevalent placental lesions among the cases were the disorders of villous maturation (31.8% [106/333] including delayed villous maturation 18.6% [62/333] vs. 1.4% [6/442], q<0.0001, prevalence ratio 13.7; and accelerated villous maturation 13.2% [44/333] vs. 0% [0/442], q<0.001). Other lesions in decreasing order of prevalence included hypercapillarized villi (15.6% [68/435] vs. 3.5% [33/938], q<0.001, prevalence ratio 4.4); nucleated red blood cells (1.1% [5/437] vs. 0% [0/938], q<0.01); chronic inflammatory lesions (47.9% [210/438] vs. 29.9% [282/944], q<0.0001, prevalence ratio 1.6); fetal inflammatory response (30.1% [132/438] vs. 23.2% [219/944], q<0.05, prevalence ratio 1.3); maternal inflammatory response (45.5% [195/438] vs. 36.1% [341/944], q<0.01, prevalence ratio 1.2); and maternal vascular malperfusion (44.5% [195/438] vs. 35.7% [337/944], q<0.01, prevalence ratio 1.2). Accelerated villous maturation did not show gestational age-dependent association with any other placental lesion while delayed villous maturation showed a gestational age-dependent association with acute placental inflammation (q-value=0.005).ConclusionsDisorders of villous maturation are present in nearly one-third of the cases of spontaneous preterm labor.
| S-EPMC8324068 | biostudies-literature
Project description:BackgroundPostpartum hemorrhage (PPH) is the leading cause of maternal mortality worldwide and accounts for one third of maternal deaths in low-income and middle-income countries. PPH can be prevented by active management of the third stage of labor (AMTSL), a series of steps recommended by the World Health Organization to be performed by skilled birth attendants (SBAs). Task shifting in the AMTSL step of uterotonic drugs administration to community health workers, traditional birth attendants and self-administration has been investigated as a strategy to increase access to quality obstetric care considering persistent SBA and facility-based delivery shortages. The aim of this study is to assess task shifting in the final step of AMTSL and compare uterine tonus assessment by a SBA to self-assessment.Methods and designThe study is an individual-level two-arm non-inferiority randomized controlled trial (RCT). A total of 800 women will be recruited in Korle Bu Teaching Hospital in Accra, Ghana. Adult women in labor at term with an expected vaginal delivery who received antenatal instructions for self-assessment of uterine tonus will be eligible for inclusion. Women with an increased risk for PPH will be excluded. Women will be randomized to uterine tone assessment by a skilled birth attendant (midwife) or uterine tone self-assessment (with the safety back-up of a midwife present in case of PPH or uterine atony). Postpartum blood loss will be measured through weighing of disposable mats. The main study endpoints are PPH (≥500 ml blood loss), severe PPH (≥1000 ml blood loss), mean blood loss, and routine maternal and neonatal outcomes. Participants and caregivers will not be blinded given the nature of the intervention.DiscussionA reduction of PPH-related maternal mortality requires full implementation of AMTSL. Task shifting of uterine tone assessment may contribute to increased AMTSL implementation in (clinical) settings where SBAs capacity is constrained.Trial registrationClinicaltrials.gov: NCT02223806 , registration August 2014.PactrPACTR201402000736158 , registration July 2014. University of Ghana, Medical School Ethical and Protocol Review Committee: MS-Et/M.8-P4.1/2014-2015.
| S-EPMC4684626 | biostudies-literature
Project description:BackgroundActive management of the third stage of labor (AMTSL) describes interventions with the common goal to prevent postpartum hemorrhage (PPH). In low- and middle-income countries, implementation of AMTSL is hampered by shortage of skilled birth attendants and a high percentage of home deliveries. Task shifting of specific AMTSL components to unskilled birth attendants or self-administration could be a strategy to increase access to potentially life-saving interventions. This study was designed to evaluate the effect, acceptance and safety of task shifting of specific aspects of AMTSL to unskilled birth attendants.MethodsA systematic search was conducted in five databases in September 2015 to identify intervention studies of AMTSL implemented by unskilled birth attendants or pregnant women themselves. Quality of studies was evaluated with an adapted Cochrane Collaboration assessment tool.ResultsOf 2469 studies screened, 21 were included. All studies assessed implementation of uterotonics (misoprostol tablets or oxytocin injections), administered by community health workers (CHWs), auxiliary midwives, traditional birth attendants (TBAs) or self-administration at antenatal (home) visits or delivery. Task shifting for none of the other AMTSL components was reported. Task shifting of provision of uterotonics reduced the risk of PPH (RR 0.16 to 1) compared to standard care (13 studies, n = 15.197). The correct dose and timing was reported for 83.4 to 99.8% (5 studies, n = 6083) and 63 to 100% (9 studies, n = 8378) women respectively. Uterotonics were recommended to others by 80 to 99.7% (7 studies, n = 6445); 80 to 99.4% (5 studies, n = 2677) would use the drug at next delivery. Willingness to pay for uterotonics varied from 54.6 to 100% (7 studies, n = 6090).ConclusionTask shifting of AMTSL has thus far been evaluated for administration of uterotonics (misoprostol tablets and oxytocin injected by CHWs and auxiliary midwives) and resulted in reduction of PPH, high rates of appropriate use and satisfaction among users. In order to increase AMTSL coverage in low-staffed health facilities, task shifting of uterine massage or postpartum tonus assessment to unskilled attendants or delivered women could be considered. Task shifting of controlled cord traction is currently not recommended.
| S-EPMC5801808 | biostudies-literature
Project description:BackgroundThis study aimed to compare the effect of breast pump stimulation with that of oxytocin administration regarding the duration of the third stage of labor, postpartum hemorrhage, and anemia after delivery.MethodsIn this study, 108 women were randomly assigned to two groups of breast pump stimulation (n = 54) and oxytocin administration (n = 54). Women in the breast stimulation group received breast pump stimulation (10 min intermittently for each breast with a negative pressure of 250 mmHg), while the women in the oxytocin (control) group received an infusion of 30 IU oxytocin in 1000 mL of Ringer's serum with a maximum rate of 10 mL infusion per min after delivery. The duration of the third stage of labor, blood loss during the third stage of labor and 24 h after delivery, hemoglobin and hematocrit (before and 24 h after delivery), after-birth pain, and the number of breastfeedings during the 24 h after delivery were recorded. The data were analyzed using the chi-square test, independent t-test, and Wilcoxon test.ResultsThe mean duration of the third stage was 5 ± 1.97 and 5.4 ± 2.5 min in the breast stimulation and women that received intravenous oxytocin respectively (p = 0.75). Most participants had mild postpartum hemorrhage (98.1 and 96.2% in the breast stimulation and women that received intravenous oxytocin, respectively, p = 0.99). Although hemoglobin and hematocrit levels significantly decreased in both groups 24 h after delivery, there was no significant difference between both groups regarding both parameters. After-birth pain was significantly lower and the number of breastfeeding during the 24 h after delivery was significantly more in the breast stimulation group compared to the control group.ConclusionsOur results demonstrated no differences between breast pump stimulation and oxytocin administration regarding the duration of the third stage of labor, postpartum hemorrhage, anaemia, after-birth pain, and the number of breastfeedings during the 24 h after delivery.Trial registration numberThe study protocol was registered in the Iranian Randomized Controlled Trial Registry (Ref. No.: IRCT2015050722146N1 ; Registration date: 2015-11-04). The study was registered prospectively and the enrollment date was 23/8/2015.
| S-EPMC6035460 | biostudies-literature
Project description:ImportanceWomen with arrested preterm labor (APTL) are at very high risk for spontaneous preterm delivery (SPTD), the leading cause of neonatal mortality and morbidity. To date, no maintenance therapy has been found to be effective for pregnancy prolongation. A few clinical trials with considerable methodological limitations have demonstrated some efficacy for 400 mg vaginal micronized progesterone (VMP) in women with APTL.ObjectiveTo investigate the effectiveness of daily 400 mg VMP for the prolongation of pregnancy after APTL.Design, setting, and participantsThis randomized clinical trial was conducted between December 19, 2018, and February 27, 2023, in 3 university-affiliated medical centers in Israel. Participants included women with singleton and twin pregnancies after APTL following tocolysis at 24 weeks 0 days to 34 weeks 0 days' gestation. Women with a history of preterm delivery or asymptomatic cervical shortening in the current pregnancy were excluded.InterventionsParticipants were randomly allocated to receive VMP 200 mg twice a day or no treatment until 36 weeks 6 days' gestation.Main outcomes and measuresThe primary end points were mean number of days from study enrollment to delivery and the rate of SPTD prior to 37 weeks' gestation.ResultsA total of 129 participants were enrolled (65 in the VMP group and 64 in the no-treatment group). Mean (SD) age was 27.6 (5.1) years. Between the VMP and no-treatment groups, there was no difference in pregnancy prolongation (mean [SD], 40.0 [17.8] vs 37.4 [20.3] days; P = .44) and the rate of SPTD (16 [25%] vs 19 [30%]; relative risk, 0.8; 95% CI, 0.5-1.5; P = .52). In twin pregnancies, including 12 and 15 pairs in the VMP and no-treatment groups, respectively, VMP prolonged pregnancy (mean [SD], 43.7 [18.1] vs 26.1 [15.2] days; P = .02), postponed the delivery week (36.5 [1.4] vs 34.7 [2.2] weeks; P = .01), shortened the length of stay in the neonatal intensive care unit (4.9 [10.6] vs 13.2 [18.5] days; P = .03) and overall hospital stay (8.3 [9.6] vs 15.1 [17.2] days; P = .03), and was associated with a higher birth weight (2444 [528] vs 2018 [430] g; P = .01).Conclusions and relevanceThese findings show that VMP given in a dosage of 200 mg twice a day following APTL is not an effective treatment to prolong pregnancy or prevent SPTD. However, VMP demonstrated beneficial effects in twin pregnancies, warranting further investigation.Trial registrationClinicalTrials.gov Identifier: NCT02430233.
| S-EPMC11231798 | biostudies-literature
Project description:ObjectiveTo assess whether providing ventilation during delayed cord clamping (V-DCC) increases placental transfusion compared with delayed cord clamping alone (DCC only).Study designInborn premature infants (230/7-316/7 weeks' gestational age) were randomized to receive at least 60 seconds of V-DCC (initial continuous positive airway pressure) with addition of positive pressure ventilation if needed) or without assisted ventilation (DCC only). For the DCC-only group, infants were dried and stimulated by gently rubbing the back if apneic. The primary outcome was the peak hematocrit in the first 24 hours of life. Delivery room outcomes were analyzed from video recordings and a data acquisition system. Hemodynamic measurements were performed with the use of functional echocardiography, near-infrared spectroscopy, and electrical cardiometry.ResultsThere was no difference in the primary outcome of peak hematocrit in the first 24 hours of life. The onset of breathing was similar between both groups (25 ± 20 and 27 ± 28 seconds, P = .627); however, infants receiving DCC received a greater duration of stimulation than V-DCC (41 ± 19 and 20 ± 21 seconds P = .002). There were no differences in delivery room interventions, early hemodynamics (cerebral oxygenation by near-infrared spectroscopy, cardiac output and stroke volume by electrical cardiometry, or superior vena cava flow by of functional echocardiography), or neonatal outcomes.ConclusionsV-DCC was feasible but did not lead to any measurable clinical improvements immediately after delivery or reduce subsequent neonatal morbidity. Caretakers should consider providing adequate stimulation before cord clamping.Trial registrationClinicalTrials.gov: NCT02231411.
| S-EPMC5527831 | biostudies-literature
Project description:BackgroundSerratiopeptidase has been clinically used in controlling surgical and non-surgical inflammatory conditions. This study was conducted to assess the therapeutic effect of Serratiopeptidase in patients undergoing surgical removal of impacted mandibular third molar.MethodsThis randomized clinical trial investigated the efficacy of Serratiopeptidase and Paracetamol after surgical removal of impacted third molar for 5 days (n = 67) as compared with an equivalent dose of placebo and Paracetamol (n = 66). Outcome measures were reported pain, trismus and swelling using Laskin method. All outcome measures were recorded on days 0, 1, 2, 4, and 5 post-surgeries.ResultsIn this clinical trail 133 patients (mean age 23 years, 54% female) completed the study. Baseline characteristics were comparable across treatment groups. Serratiopeptidase significantly improved trismus compared with control on the 4th day (27.30 ± 7.3 mm and 32.06 ± 7.7 mm, respectively (P < 0.001) Swelling markedly improved, The distance from the lower edge of the earlobe to the midpoint of the symphysis for cases vs control were 111.49 ± 8.1 mm and 115.39 ± 9.9 mm, respectively (P < 0.001). Reported pain, showed no statistical significance difference.ConclusionSerratiopeptidase resulted in better inflammation improvement than placebo over 5 days. Further studies are warranted to assess longer-term and clinical outcomes, as well as safety.Clinical relevanceSerratiopeptidase administered postoperatively helps in improving trismus and swelling after removal of impacted lower third molars. Trial registration The study was registered in ClinicalTrial.gov under the number NCT02493179. Registered 1st of June 2015, https://clinicaltrials.gov/ct2/results?cond=serratiopeptidase .
| S-EPMC7927242 | biostudies-literature