Christine E East1, Emma Df Dorward2, Rhiannon E Whale3, Jiajia Liu4. 1. School of Nursing and Midwifery, La Trobe University/Mercy Hospital for Women, Bundoora, Australia. 2. Glen Iris, Australia. 3. Melbourne, Australia. 4. Antenatal/Postnatal Ward, Mercy Hospital for Women, Heidelberg, Australia.
Abstract
BACKGROUND: 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. OBJECTIVES: 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. SEARCH METHODS: 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. SELECTION CRITERIA: Published and unpublished randomised and quasi-randomised trials (RCTs) that compared a localised cooling treatment applied to the perineum with no treatment, placebo, or another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. DATA COLLECTION AND ANALYSIS: 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. MAIN RESULTS: 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.
BACKGROUND: 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. OBJECTIVES: 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. SEARCH METHODS: 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. SELECTION CRITERIA: 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. DATA COLLECTION AND ANALYSIS: 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. MAIN RESULTS: 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.