Table 2 Descriptive data of studies included in the meta-analysis
Reference | GA range | N (ITT) | Women excluded from reference analysis | Rationale for exclusion from reference analysis | Exclusion of women with history or active bleeding | Reference method | N (PP) | Women excluded from meta-analysis | Rationale for exclusion of women from meta-analysis |
|---|---|---|---|---|---|---|---|---|---|
Actim® PROM (IGFBP-1) | |||||||||
Rutanen 1996 [12] | 15–37 | 311 | 0 | -- | No | For women with suspected ROM but equivocal diagnosis, ROM was assessed based on the interval between sampling and delivery. | 130 | 181 | Women with suspected ROM but inadequate reference method to confirm PROM. |
Ragosch 1996 [50] | 22-41 | 75 | 0 | -- | Yes | Clinical confirmation in cases of obvious PROM. Women with unconfirmed PROM underwent amniocentesis (if patient consented). | 75 | 0 | |
Gaucherand 1997 [53] | 19-41 | 100 | 0 | -- | No | Clinical course and similarity of the majority of the three tests: Actim® PROM, DAO and pH. | 69 | 31 | Women with suspected ROM and PROM confirmation absent. |
Jain 1998 [49] | 24-42 | 100 | 0 | -- | No | Pooling of liquid in the posterior fornix or seen leaking from the cervix. | 100 | 0 | -- |
Kubota 1998 [46] | 15-41 | 48 | 0 | -- | No | At delivery and/or by observing the subsequent clinical course. | 48 | -- | |
Darj 1998 [51] | 25-42 | 174 | 0 | -- | No | Delivery within 48 hours. Method not available for women with suspected PROM. | 75 | 99 | Women with suspected ROM but inadequate reference method to confirm PROM. |
Guibourdenche 1999 [48] | 18-41 | 80 | 0 | -- | No | For women with suspected PROM, diagnosis was confirmed using detection of diamine oxidase in vaginal secretions (detected by semi-quantitative radio-enzymatic assay). | 30 | 50 | Women with suspected ROM and PROM confirmation absent. |
Erdermoglu 2004 [47] | 20-42 | 151 | 0 | -- | No | Speculum examination at inclusion. Later diagnosis in suspected women was associated with delivery within the next 7 days following the test. | 71 | 80 | Women with suspected ROM but PROM confirmation absent. |
Akercan 2005 [54] | 20-36 | 87 | 6 | Lost on follow-up (4) and 2 who refused hospital admission. | Yes | Ongoing vaginal fluid leakage and/or ruptured amniotic membranes at first vaginal examination. Pooling of amniotic fluid in the posterior fornix. | 45 | 36 | Women with suspected ROM but inadequate reference method to confirm PROM. |
Martinez de Tejada 2006 [52] | 24-41 | 83 | 0 | -- | No | Presence of AF in the vagina or total absence of vaginal secretions, alkaline pH, positive fern test, oligohydramnios (AFI <5 cm), chorioamnionitis, absence or very little amount of AF leakage during labour and delivery. | 83 | 0 | -- |
Tagore 2010 [59] | 17-37 | 100 | 6 | Not specified on paper. | Yes | Three or more of: definite pooling of clear fluid during speculum examination, oligohydramnios on ultrasound, signs and symptoms of chorioamnionitis and preterm delivery within a week of presentation along with convincing history of leaking liquor. | 94 | 0 | -- |
Albayrak 2011 [61] | 16-41 | 179 | 12 | Lost on follow-up. | Yes | Speculum examination (clear fluid leakage) and two of: sonographic AFI, Fern, pH. Further dx was confirmed based on the duration of latency period, results of repeat speculum examinations, repeat ferning, nitrazine and strip tests and decrease of AFI, and clinical signs of foetal distress or chorioamnionitis. | 167 | 0 | -- |
Marcellin 2011 [60] | Not specified | 80 | 1 | Patient from the PROM group with placenta previa. | Not specified | Evident liquid outlet at vaginal examination. | 79 | 0 | -- |
AmniSure® (PAMG-1) | |||||||||
Cousins 2005 [55] | 15-42 | 203 | 0 | -- | Yes | Two of: visual pooling of AF, alkaline pH, positive Fern test. | 203 | 0 | -- |
Lee SE 2007 [56] | 11-42 | 184 | 1 | Lost on follow-up. | Yes | Leaking from the cervical OS on speculum examination or two of: visual pooling of fluid in the posterior fornix, positive nitrazine test or positive fern test. | 183 | 0 | -- |
Tagore 2010 [59] | 17-37 | 100 | 0 | -- | Yes | Three or more of: definite pooling of clear fluid during speculum examination, oligohydramnios on ultrasound, signs and symptoms of chorioamnionitis and preterm delivery within a week of presentation along with convincing history of leaking liquor. | 100 | 0 | -- |
Marcellin 2011 [60] | Not specified | 80 | 1 | Patient from the PROM group with placenta previa. | Not specified | Evident liquid outlet at vaginal examination. | 79 | 0 | -- |
Albayrak 2011 [61] | 16-41 | 179 | 12 | Lost on follow-up. | Yes | Speculum examination (clear fluid leakage) and two of: sonographic AFI, Fern, pH. Further diagnosis was confirmed based on the duration of latency period, results of repeat speculum examinations, repeat ferning, nitrazine and strip tests and decrease of AFI, and clinical signs of foetal distress or chorioamnionitis. | 167 | 0 | -- |
Birkenmaier 2012 [57] | 17-42 | 202 | 3 | Excluded retrospectively due to incomplete medical records. | Yes | Two of: visual leaking or pooling of AF from the cervix on the speculum examination, positive nitrazine test or AFI <5 cm in the ultrasound examination. Definitive dx was diagnosed on review of medical records when there was documented evidence of intact or ruptured membranes with consecutive loss of fluid during delivery. | 199 | 0 | -- |
Abdelazim 2012 [58] | >37 | 150 | 0 | -- | Yes | History of sudden gush of water, pooling of AF, positive ferning pattern, positive nitrazine test and confirmed by visualisation of fluid passing from the cervical canal during sterile speculum examination. | 150 | 0 | -- |