Dilapan-S vs standard methods for cervical ripening in term pregnancies: an individual patient data meta-analysis.
Dilapan-S is a cervical ripening agent approved by the FDA that has been found to be just as effective as other agents and can be utilized for outpatient ripening. No large-scale studies have been conducted to compare cesarean delivery rates between Dilapan-S and other ripening methods. Our objective was to combine these trials to compare cesarean delivery rates for Dilapan-S with other cervical ripening methods, overall and in sub-groups.
The time period for this study was from January 1994 to April 2023. Ovid MEDLINE, Embase via Ovid, Ovid Emcare, CINAHL Plus, ClinicalTrials.gov, euclinicaltrialsregister.eu, and Scopus were searched. The study was conducted according to the Preferred Reporting Item for Systematic Reviews guidelines and was registered with PROSPERO (CRD42023423573).
This was a systematic review and meta-analysis of individual patient data from randomized controlled trials comparing Dilapan-S to other mechanical or pharmacologic cervical ripening methods for labor induction in singleton gestations. The main outcome measure assessed was the cesarean delivery (CD) rate in comparing Dilapan-S to alternative methods. Secondary maternal outcomes included changes in Bishop score postintervention, vaginal delivery without complications, postpartum hemorrhage, cervical ripening issues, uterine infection, and patient satisfaction. Secondary neonatal outcomes were Apgar score <7 at 5 minutes, arterial cord pH <7.1, meconium presence, NICU admission and length of stay, hypoxic-ischemic encephalopathy, intraventricular hemorrhage, infant infection, and infant death. This study exclusively included randomized controlled trials (RCTs) involving participants who underwent labor induction during the third trimester of a singleton pregnancy. At least one group within these trials received Dilapan-S for the purpose of cervical ripening. Trials were excluded if induction occurred prior to 37 weeks of gestation or if cervical ripening was deemed unnecessary.
Two reviewers independently selected studies, assessed the risk of bias using the Cochrane Risk of Bias Tool for RCTs, and extracted the data. Prespecified subgroup analysis was performed for parity, body mass index, Bishop score, and gestational age. Pooled odds ratios (ORs) adjusted for maternal age and parity with 95% confidence intervals (CI) were calculated using frequentist and Bayesian approaches.
Four RCTs were identified, with 1731 women included (1036 allocated to Dilapan-S; 695 to alternative cervical ripening methods). CD rates were 28% and 30% with Dilapan-S and other methods, respectively. There was no difference in maternal age and parity-adjusted CD rates between Dilapan-S and other methods (OR 1.03, 95% CI 0.8-1.3). Bayesian inference indicated a 95% probability of being noninferior (5% margin) and a 4.5% probability of being inferior to other methods. Subgroup analysis demonstrated significant interaction with parity with a 99% probability of lowering cesarean rates among multiparous women treated with Dilapan-S (RR 0.61, 95% CrI 0.4-0.9) compared to a 6% probability of benefit among nulliparous women (RR 1.13, 95% CrI 0.97-1.33). Pain levels ≥4 were significantly lower in the Dilapan-S group (46% vs 62%; OR 0.5, 95% CI 0.40-0.64). Complication rates during cervical ripening (uterine hypertonus, uterine tachysystole, nonreassuring fetal heart tracing, and others) were also lower in the Dilapan-S group (19% vs 47%; OR 0.28, 95% CI 0.28-0.37). Higher patient satisfaction was reported with Dilapan-S.
Dilapan-S was at least noninferior and marginally superior in lowering cesarean rates compared to other preinduction cervical ripening agents. Parity impacted efficacy, with multiparous women benefiting the most.
Saad AF
，Pedroza C
，Gavara R
，Gupta J
，Wapner RJ
，Saade GR
... -
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Cell salvage for the management of postpartum haemorrhage.
Postpartum haemorrhage (PPH), defined as a blood loss of 500 mL or more within 24 hours of birth, is the leading global cause of maternal morbidity and mortality. Allogenic blood transfusions are a critical component of PPH management, yet are often unfeasible, particularly in resource-poor settings where maternal morbidity is highest. Autologous cell salvage in the management of PPH has been proposed to combat limitations in access to allogenic blood and potential transfusion-related risks. This review examines the benefits and harms of using cell salvage for pregnant women during birth.
To assess the benefits and harms of cell salvage when used during birth.
We searched the CENTRAL, MEDLINE, Ovid Embase, and Global Index Medicus databases and the ICTRP and ClinicalTrials.gov trials registers. We also carried out reference checking and citation searching, and contacted study authors to identify all relevant studies. The latest search date was 8 February 2024.
We included randomised controlled trials (RCTs) in pregnant women (24 weeks or more gestation) comparing use of cell salvage following caesarean or vaginal birth with routine care (defined as no cell salvage). We did not place any restrictions on mode of birth, ethnicity, race, socioeconomic status, education level, or place of residence.
Critical outcomes for this review were risk of allogenic blood transfusion, risk of transfusion-related adverse reactions, risk of haemorrhage, transfer to higher level of care, length of hospitalisation, length of operation, and risk of sepsis. Important outcomes were estimated blood loss, blood loss ≥ 500 mL, blood loss ≥ 1000 mL, use of additional uterotonics or tranexamic acid, maternal death, postpartum haemoglobin concentration, change in haemoglobin, major surgery including hysterectomy, future major surgery, end-organ dysfunction or failure, amniotic fluid embolism, side effects, clotting abnormalities, maternal experience/satisfaction, maternal well-being, and breastfeeding.
We assessed risk of bias using the Cochrane risk of bias tool (RoB 1) for each critical outcome from each RCT.
We conducted a meta-analysis for each outcome where data were available from more than one study using a random-effects model. If data could not be analysed using meta-analysis, we synthesised results narratively using the Synthesis Without Meta-analysis (SWiM) guidance. We used GRADE to assess the certainty of evidence for each outcome.
We included six RCTs with 3476 participants. All trials involved pregnant women having a caesarean birth. Three trials were conducted in high-income countries, and three were conducted in an upper-middle-income country.
Allogenic blood transfusion Intraoperative cell salvage at caesarean birth may reduce the need for allogenic transfusions received by participants, although the 95% confidence interval (CI) includes the possibility of an increase in effect. Low-certainty evidence from three studies found the risk of donor transfusions was possibly lower in participants with cell salvage (risk ratio (RR) 0.45, 95% CI 0.15 to 1.33; P = 0.15, I2 = 33%; 3 RCTs, 3115 women; low-certainty evidence). The absolute risk of transfusion was very low in the studies (4% in women not treated with cell salvage and 2% in women treated with cell salvage). Transfusion-related adverse reactions The evidence is very uncertain about the risk of transfusion-related adverse reactions in participants with intraoperative cell salvage (RR 0.48, 95% CI 0.09 to 2.62; P = 0.39; 4 RCTs, 3304 women; very low-certainty evidence). Haemorrhage Two studies reported risk of haemorrhage and found that there was probably no difference between arms (RR 0.88, 95% CI 0.67 to 1.15; P = 0.36, I² = 0%; 2 RCTs, 3077 women; moderate-certainty evidence). Length of hospitalisation The evidence is very uncertain about whether interoperative cell salvage at caesarean birth affects length of hospitalisation. Three studies reported length of hospitalisation (MD -2.02 days, 95% CI -4.73 to 0.70; P = 0.15, I2 = 100%; 3 RCTs, 3174 women; very low-certainty evidence). Length of operation Two studies reported on length of operation. However, meta-analysis was not possible due to statistical heterogeneity and divergence of study findings; the direction of effect could not be determined. We evaluated the evidence as very low certainty. Sepsis One study reported risk of sepsis, finding that there was possibly no difference between arms (RR 1.00, 95% CI 0.43 to 2.29; P = 0.99; 1 RCT, 2990 women; low-certainty evidence). Estimated blood loss Cell salvage at caesarean birth may reduce blood loss. Two studies reported that estimated blood loss was possibly lower in women who had cell salvage compared to those who did not (MD -113.59 mL, 95% CI -130.41 to -96.77; P < 0.00001, I2 = 0%; 2 RCTs, 246 women; low-certainty evidence). Postpartum haemoglobin concentration Cell salvage at caesarean birth may increase day one postpartum haemoglobin. Three studies reported day one postpartum haemoglobin levels (MD 6.14 g/L, 95% CI 1.62 to 10.65; P = 0.008, I2 = 97%; 3 RCTs, 3070 women; low-certainty evidence). Amniotic fluid embolism Three trials reported risk of amniotic fluid embolism and no cases were observed (n = 3226 women).
Cell salvage may reduce the need for allogenic blood transfusion, may reduce blood loss, and may increase day one postpartum haemoglobin in pregnant women having caesarean birth (low certainty). Cell salvage may make little to no difference to the risk of sepsis (low certainty) and probably makes little to no difference to the risk of haemorrhage (moderate certainty). The effect of cell salvage on risk of transfusion-related adverse reactions is very uncertain. The effect of cell salvage on the length of hospital stay was both clinically and statistically heterogenous, with a very low certainty of evidence. The effect of cell salvage on length of operation is divergent and meta-analysis was not possible due to significant statistical heterogeneity; the evidence is of very low certainty. No cases of amniotic fluid embolism were reported among the included trials. Studies in low- and middle-income settings are needed.
This review had no dedicated funding.
This review was registered with PROSPERO (CRD42024554204).
Dey T
，Brown D
，Cole MG
，Hill RA
，Chaplin M
，Huffstetler HE
，Curtis F
... -
《Cochrane Database of Systematic Reviews》
Cervical balloon catheter versus Dilapan-S for outpatient cervical ripening: A randomized controlled trial.
As induction of labor increases in the United States, safe, effective outpatient cervical ripening has been explored as a method to decrease the inpatient time burden. The most effective method of outpatient mechanical cervical ripening remains unclear.
To evaluate if Dilapan-S is non-inferior to cervical balloon for outpatient cervical ripening (CR) based on change in Bishop score.
This was a single-blind, randomized controlled trial at a single tertiary hospital. Term patients, both nulliparous and multiparous, aged 18-50 with a singleton, cephalic fetus and no prior c-section who were scheduled for outpatient CR per pre-existing hospital policy were eligible. Participants were randomized to single balloon cervical ripening with a Cook catheter with 60mL in the intrauterine balloon or placement of 3 to 5 Dilapan-S hydroscopic dilators and were then discharged home. On return to the hospital, the CR agent was removed, a blinded cervical exam performed, and participants completed a satisfaction survey. Further induction proceeded per their obstetrical provider. The primary outcome was change in Bishop score. Secondary outcomes included patient satisfaction, mode of delivery, induction time, adverse maternal and neonatal outcomes and a cervical ripening failure composite (failure to place randomized cervical ripening agent, prelabor rupture of membranes prior to scheduled return to hospital, significant vaginal bleeding, or need for further cervical ripening after the initial agent is removed) .We had 80% power to show non-inferiority in change in Bishop score with a margin of 2 and standard deviation of 3.
From May 2022 to June 2023, 80 participants were randomized with no difference in baseline demographic data, starting dilation, or Bishop score. 70% of participants in each arm were nulliparous. There was no difference in change in Bishop score between Dilapan-S and cervical balloon (median change 3 (interquartile range (IQR) 2-5) vs 3 (IQR2-4.5) respectively, p=0.91). There was no difference in time to delivery, mode of delivery, or maternal or neonatal outcomes. Participants randomized to Dilapan-S were more satisfied with their experience (satisfaction scale 0-10, median 9 (IQR 8-10) vs 8 (IQR 5-9), p<0.01) and were less likely to experience cervical ripening failure (7(17.5%) vs 18(45%), p<0.01) compared to participants who were randomized to cervical balloon.
Dilapan-S was non-inferior to cervical balloon catheter for outpatient cervical ripening based on change in Bishop score. Participants were more satisfied with Dilapan-S and less likely to experience cervical ripening failure compared to a cervical catheter with single balloon inflation.
Wood RL
，Bluemm C
，Lassey SC
，Little SE
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ResearchGate
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