101: Do other elements of the obstetrical history provide a possible indication for progesterone supplementation? Secondary analysis from the progesterone vaginal gel trial

ObjectiveBecause obstetrical history can identify populations at varied risk for preterm birth, we desired to assess the utility of progesterone therapy for the prevention of recurrent preterm birth in subgroups whose risk profile varied based on element in their history.Study DesignA secondary analysis was performed of women enrolled into a preterm prevention trial utilizing Procheive® 8% (90 mg) intravaginal, daily progesterone gel or placebo. Fisher′s exact test and Cochran-Mantel-Haenszel (CMH) test were utilized to compare outcomes in defined subgroups based on number of prior preterm birth and gestational age at preterm birth.Results668 women were enrolled in the trial with data available for analysis in 620 participants. Demographic characteristics were similar between the groups. The rate of preterm birth ≤32 weeks is shown in the Table. No single subgroup, based on obstetric historical factors, benefitted more than the others, P = 0.49 by CMH for each analysis.Tabled 1Response to Progesterone Therapy Based on Elements of Obstetrical HistoryNumber of PTBsTreated, n (%)Placebo, n (%)P valueSingle (n=462)20 of 236 (8.5)21 of 226 (9.3).870Multiple (n=152)10 of 73 (13.7)15 of 79 (19.0).512Timing of Prior PTBs<28 weeks (n=160)14 of 81 (17.3)13 of 79 (16.5)1.028+0 to 31+6 (n=168)10 of 80 (12.5)11 of 88 (12.5)1.0≥32 weeks (n=262)5 of 138 (3.6)10 of 124 (8.1).182 Open table in a new tab ConclusionUtilizing a particular element of obstetrical history to define an indication for progesterone supplementation is not supported by these data. ObjectiveBecause obstetrical history can identify populations at varied risk for preterm birth, we desired to assess the utility of progesterone therapy for the prevention of recurrent preterm birth in subgroups whose risk profile varied based on element in their history. Because obstetrical history can identify populations at varied risk for preterm birth, we desired to assess the utility of progesterone therapy for the prevention of recurrent preterm birth in subgroups whose risk profile varied based on element in their history. Study DesignA secondary analysis was performed of women enrolled into a preterm prevention trial utilizing Procheive® 8% (90 mg) intravaginal, daily progesterone gel or placebo. Fisher′s exact test and Cochran-Mantel-Haenszel (CMH) test were utilized to compare outcomes in defined subgroups based on number of prior preterm birth and gestational age at preterm birth. A secondary analysis was performed of women enrolled into a preterm prevention trial utilizing Procheive® 8% (90 mg) intravaginal, daily progesterone gel or placebo. Fisher′s exact test and Cochran-Mantel-Haenszel (CMH) test were utilized to compare outcomes in defined subgroups based on number of prior preterm birth and gestational age at preterm birth. Results668 women were enrolled in the trial with data available for analysis in 620 participants. Demographic characteristics were similar between the groups. The rate of preterm birth ≤32 weeks is shown in the Table. No single subgroup, based on obstetric historical factors, benefitted more than the others, P = 0.49 by CMH for each analysis.Tabled 1Response to Progesterone Therapy Based on Elements of Obstetrical HistoryNumber of PTBsTreated, n (%)Placebo, n (%)P valueSingle (n=462)20 of 236 (8.5)21 of 226 (9.3).870Multiple (n=152)10 of 73 (13.7)15 of 79 (19.0).512Timing of Prior PTBs<28 weeks (n=160)14 of 81 (17.3)13 of 79 (16.5)1.028+0 to 31+6 (n=168)10 of 80 (12.5)11 of 88 (12.5)1.0≥32 weeks (n=262)5 of 138 (3.6)10 of 124 (8.1).182 Open table in a new tab 668 women were enrolled in the trial with data available for analysis in 620 participants. Demographic characteristics were similar between the groups. The rate of preterm birth ≤32 weeks is shown in the Table. No single subgroup, based on obstetric historical factors, benefitted more than the others, P = 0.49 by CMH for each analysis. ConclusionUtilizing a particular element of obstetrical history to define an indication for progesterone supplementation is not supported by these data. Utilizing a particular element of obstetrical history to define an indication for progesterone supplementation is not supported by these data.