East Christine E, Dorward Emma Df, Whale Rhiannon E, Liu Jiajia
School of Nursing and Midwifery, La Trobe University/Mercy Hospital for Women, Bundoora, Australia.
Glen Iris, Australia.
Cochrane Database Syst Rev. 2020 Oct 9;10(10):CD006304. doi: 10.1002/14651858.CD006304.pub4.
Perineal trauma is common during childbirth and may be painful. Contemporary maternity practice includes offering women numerous forms of pain relief, including the local application of cooling treatments. This Cochrane Review is an update of a review last updated in 2012.
To evaluate the effectiveness of localised cooling treatments compared with no treatment, placebo, or other cooling treatments applied to the perineum for pain relief following perineal trauma sustained during childbirth.
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (7 October 2019) and reference lists of retrieved studies.
Published and unpublished randomised and quasi-randomised trials (RCTs) that compared a localised cooling treatment applied to the perineum with no treatment, placebo, or another cooling treatment applied to relieve pain related to perineal trauma sustained during childbirth.
Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies. Data were double checked for accuracy. The certainty of the evidence was assessed using the GRADE approach.
We included 10 RCTs that enrolled 1233 women randomised to the use of one cooling treatment (ice, cold gel pad, cooling plus compression, cooling plus compression plus (being) horizontal) compared with another cooling treatment, no treatment, or placebo (water pack, compression). The included trials were at low or uncertain risk of bias overall, with the exception that the inability to blind participants and personnel to group allocation meant that we rated all trials at unclear or high risk for this domain. We undertook a number of comparisons to evaluate the different treatments. Cooling treatment (ice pack or cold gel pad) versus no treatment There was limited very low-certainty evidence that cooling treatment may reduce women's self-reported perineal pain within four to six hours (mean difference (MD) -4.46, 95% confidence interval (CI) -5.07 to -3.85 on a 10-point scale; 1 study, 100 participants) or between 24 and 48 hours of giving birth (risk ratio (RR) 0.73, 95% CI 0.57 to 0.94; 1 study, 316 participants). The evidence is very uncertain about the various measures of wound healing, for example, wound edges gaping when inspected five days after giving birth (RR 2.56, 95% CI 0.58 to 11.33; 1 study, 315 participants). Women generally rated their satisfaction with perineal care similarly following cooling or no treatment. The potential exception was that there may be a trivially lower mean difference of -0.1 on a five-point scale of psychospiritual comfort with cooling treatment, that is unlikely to be of clinical importance. Cooling treatment (cold gel pad) + compression versus placebo (gel pad + compression) There was limited low-certainty evidence that there may be a trivial MD of -0.43 in pain on a 10-point scale at 24 to 48 hours after giving birth (95% CI -0.73 to -0.13; 1 study, 250 participants) when a cooling treatment plus compression from a well-secured perineal pad was compared with the placebo. Levels of perineal oedema may be similar for the two groups (low-certainty evidence) and perineal bruising was not observed. There was low-certainty evidence that women may rate their satisfaction as being slightly higher with perineal care in the cold gel pad and compression group (MD 0.88, 95% CI 0.38 to 1.38; 1 trial, 250 participants). Cooling treatment (ice pack) versus placebo (water pack) One study reported that no women reported pain after using an ice pack or a water pack when asked within 24 hours of giving birth. There was low-certainty evidence that oedema may be similar for the two groups when assessed at four to six hours (RR 0.96, 95% CI 0.50 to 1.86; 1 study, 63 participants) or within 24 hours of giving birth (RR 0.36, 95% CI 0.08 to 1.59). No women were observed to have perineal bruising at these times. The trialists reported that no women in either group experienced any adverse effects on wound healing. There was very low-certainty evidence that women may rate their views and experiences with the treatments similarly (for example, satisfied with treatment: RR 0.91, 95% CI 0.77 to 1.08; 63 participants). Cooling treatment (ice pack) versus cooling treatment (cold gel pad) The evidence is very uncertain about the effects of using ice packs or cold gel pads on women's self-rated perineal pain, on perineal bruising, or on perineal oedema at four to six hours or within 24 hours of giving birth. Perineal oedema may persist 24 to 48 hours after giving birth in women using the ice packs (RR 1.69, 95% CI 1.03 to 2.7; 2 trials, 264 participants; very low-certainty). The risk of gaping wound edges five days after giving birth may be decreased in women who had used ice packs (RR 0.22, 95% CI 0.05 to 1.01; 215 participants; very low-certainty). However, this did not appear to persist to day 10 (RR 3.06, 95% CI 0.63 to 14.81; 214 participants). Women may rate their opinion of treatment less favourably following the use of ice packs five days after giving birth (RR 0.33, 95% CI 0.17 to 0.68; 1 study, 49 participants) and when assessed on day 10 (RR 0.82, 95% CI 0.73 to 0.92; 1 study, 208 participants), both very low-certainty.
AUTHORS' CONCLUSIONS: There is limited very low-certainty evidence that may support the use of cooling treatments, in the form or ice packs or cold gel pads, for the relief of perineal pain in the first two days following childbirth. It is likely that concurrent use of several treatments is required to adequately address this issue, including prescription and non-prescription analgesia. Studies included in this review involved the use of cooling treatments for 10 to 20 minutes, and although no adverse effects were noted, these findings came from studies of relatively small numbers of women, or were not reported at all. The continued lack of high-certainty evidence of the benefits of cooling treatments should be viewed with caution, and further well-designed trials should be conducted.
会阴创伤在分娩过程中很常见,且可能会引起疼痛。当代产科实践为女性提供了多种止痛方式,包括局部应用冷敷治疗。本Cochrane系统评价是对2012年上次更新的评价的更新。
评估局部冷敷治疗与未治疗、安慰剂或其他用于会阴创伤后止痛的冷敷治疗相比的有效性。
我们检索了Cochrane妊娠与分娩试验注册库、ClinicalTrials.gov、世界卫生组织国际临床试验注册平台(ICTRP)(2019年10月7日)以及检索到的研究的参考文献列表。
已发表和未发表的随机及半随机试验(RCT),这些试验比较了应用于会阴的局部冷敷治疗与未治疗、安慰剂或另一种用于缓解分娩时会阴创伤相关疼痛的冷敷治疗。
两位评价作者独立评估研究的纳入资格、提取数据并评估纳入研究的偏倚风险。数据进行了准确性的二次核对。使用GRADE方法评估证据的确定性。
我们纳入了10项RCT,共1233名女性被随机分配使用一种冷敷治疗(冰袋、冷凝胶垫、冷敷加压迫、冷敷加压迫加水平卧位),并与另一种冷敷治疗、未治疗或安慰剂(水袋、压迫)进行比较。纳入的试验总体偏倚风险较低或不确定,唯一的例外是参与者和研究人员无法对分组分配进行盲法,这意味着我们将所有试验在该领域的偏倚风险评为不清楚或高风险。我们进行了多项比较以评估不同的治疗方法。冷敷治疗(冰袋或冷凝胶垫)与未治疗:有有限的极低确定性证据表明,冷敷治疗可能在4至6小时内减轻女性自我报告的会阴疼痛(10分制下平均差(MD)为-4.46,95%置信区间(CI)为-5.07至-3.85;1项研究,100名参与者),或在分娩后24至48小时内减轻疼痛(风险比(RR)为0.73,95%CI为0.57至0.94;1项研究,316名参与者)。关于伤口愈合的各种测量指标,证据非常不确定,例如,分娩后五天检查时伤口边缘裂开情况(RR为2.56,95%CI为0.58至11.33;1项研究,315名参与者)。女性在接受冷敷或未治疗后,对会阴护理的满意度评分通常相似。可能的例外是,在五点制的心理精神舒适度评分上,冷敷治疗的平均差可能略低-0.1,这不太可能具有临床重要性。冷敷治疗(冷凝胶垫)+压迫与安慰剂(凝胶垫+压迫):有有限的低确定性证据表明,当将一种冷敷治疗加用固定良好的会阴垫压迫与安慰剂进行比较时,在分娩后24至48小时,10分制疼痛评分上可能存在微不足道的MD为-0.43(95%CI为-0.73至-0.13;1项研究,250名参与者)。两组的会阴水肿程度可能相似(低确定性证据),且未观察到会阴瘀伤。有低确定性证据表明,冷凝胶垫加压迫组的女性对会阴护理的满意度评分可能略高(MD为0.88,95%CI为0.38至1.38;1项试验,250名参与者)。冷敷治疗(冰袋)与安慰剂(水袋):一项研究报告称,在分娩后24小时内询问时,使用冰袋或水袋后均无女性报告疼痛。有低确定性证据表明,在4至6小时(RR为0.96,95%CI为0.50至1.86;1项研究,63名参与者)或分娩后24小时内评估时,两组的水肿情况可能相似(RR为0.36,95%CI为0.08至1.59)。在这些时间未观察到女性会阴瘀伤。试验者报告称,两组中均无女性在伤口愈合方面出现任何不良反应。有极低确定性证据表明,女性对这些治疗的看法和体验可能相似(例如,对治疗满意:RR为0.91,95%CI为0.77至1.08;63名参与者)。冷敷治疗(冰袋)与冷敷治疗(冷凝胶垫):关于使用冰袋或冷凝胶垫对女性自我评定的会阴疼痛、会阴瘀伤或分娩后4至6小时或24小时内的会阴水肿的影响,证据非常不确定。使用冰袋的女性在分娩后24至48小时会阴水肿可能持续存在(RR为1.69,95%CI为1.03至2.7;2项研究,264名参与者;极低确定性)。使用冰袋的女性在分娩后五天伤口边缘裂开的风险可能降低(RR为0.22,95%CI为0.05至1.01;215名参与者;极低确定性)。然而,这种情况似乎在第10天并未持续(RR为3.06,95%CI为0.63至14.81;214名参与者)。使用冰袋的女性在分娩后五天对治疗的评价可能较低(RR为0.33,95%CI为0.17至0.68;1项研究,49名参与者),在第十天评估时也是如此(RR为0.82,95%CI为0.73至0.92;1项研究,208名参与者),两者均为极低确定性。
有有限的极低确定性证据可能支持在分娩后的前两天使用冰袋或冷凝胶垫形式的冷敷治疗来缓解会阴疼痛。可能需要同时使用多种治疗方法来充分解决这个问题,包括处方和非处方镇痛。本评价纳入的研究中冷敷治疗使用时间为10至20分钟,尽管未观察到不良反应,但这些发现来自相对少数女性的研究,或者根本未报告。对于冷敷治疗益处的高确定性证据持续缺乏,应谨慎看待,需要进行进一步设计良好的试验。