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Trial of instrumental delivery in theatre versus immediate caesarean section for anticipated difficult assisted births

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To determine differences in maternal and neonatal morbidity for women where a trial of anticipated difficult instrumental vaginal delivery is conducted in theatre compared to women who have immediate caesarean section in the second stage for maternal or fetal indications.

Background

The majority of women have spontaneous vaginal birth but some women need assistance with delivery of the baby in the second stage of labour. Instrumental vaginal delivery is when obstetric forceps or the vacuum extractor is used to assist delivery of the baby. Rates of instrumental vaginal delivery range between 5% to 20% of all births in industrialised countries (Janni 2002; Roberts 2002a). Indications for instrumental vaginal delivery may be for fetal or maternal reasons or for both. Fetal conditions in which instrumental vaginal delivery may be required include fetal heart rate abnormality and malposition of the fetal head such as occipito‐posterior position. Maternal exhaustion and medical conditions in which expulsive effort must be reduced such as cardiac disease may necessitate an assisted second stage. The majority of instrumental vaginal deliveries are conducted in the delivery room but in a small proportion (2% to 5%) a trial of instrumental vaginal delivery is conducted in theatre with preparations made for proceeding to caesarean section (Mola 2002; Murphy 2001b). Although all instrumental vaginal deliveries can be considered a trial, there are clinical factors such as malposition and level of presenting part may influence the operator in deciding on delivery in the room or in theatre. However, there are no agreed criteria for a trial of instrumental vaginal delivery in theatre. The decision to attempt instrumental vaginal delivery in theatre is subjective with wide variation between practitioners and is influenced by the local practical arrangements for conducting a trial in theatre.

Some trials of instrumental vaginal delivery fail to complete delivery by the vaginal route and caesarean section is performed. Failure rates of instrumental vaginal delivery range from 16% to 20% (Cheong 2004; Sau 2004). Failed trial of instrumental vaginal delivery in theatre is associated with a shorter interval between failure of trial and delivery by caesarean section when compared to a failed attempt conducted in the delivery room. Factors that reduce chances of successful trial of instrumental vaginal delivery include nulliparity, malposition of the fetal head, high level of head, deflexed head and reduced pelvic capacity (Al‐Kadri 2003). The skills of the operator affect outcome of trial of instrumental vaginal delivery. An experienced practitioner is likely to have a higher success rate by careful patient selection. A cautious less experienced operator may also have a high success rate through conducting the majority of instrumental vaginal deliveries as trials in theatre. In some settings there are protocols for a trial of instrumental vaginal delivery in theatre such as requiring senior obstetrician approval.

The second stage of labour is defined as the interval between achieving full cervical dilatation and delivery of the baby. The second stage can be subdivided into a passive phase where the woman has no urge to push and an active phase when the woman is bearing down during contractions. During the passive phase the presenting part descends to below the ischial spines and the fetal head tends to rotate to an occipito‐anterior position. The optimal duration of the second stage remains undefined but a mean of 70 minutes, with 79% of women experiencing a second stage of less than two hours has been reported (Janni 2002). There is, however, no evidence that a second stage lasting more than two hours was detrimental to the fetus if adequate monitoring was provided. The duration of the second stage can be affected by use of analgesia especially epidural that may remove urge to push (Liu 2004; Zhang 2001). In women with an epidural, directed pushing should be discouraged until the presenting part descends below the spines. Delaying pushing to more than two hours after full cervical dilatation reduces difficult deliveries (Fraser 2000). The phase of active pushing is accompanied by a decline in fetal pH and there are recommendations for this to be shortened (Roberts 2003). The second stage is generally shorter in multiparous women. Failure to progress in the second stage may be due to malposition of the fetal head, ineffective uterine contractions or feto‐pelvic disproportion. An oxytocin infusion commenced in the second stage to correct ineffective uterine contractions shortens the second stage and reduces instrumental deliveries. It is recommended that the active phase should not exceed an hour in primigravida and should be shorter in multiparous women (Murphy 2001a; Sizer 2000). Increased rates of caesarean section, instrumental vaginal delivery and perineal trauma (third and fourth degree tears) with second stage longer than one hour have been reported (Cheng 2004). Although length of the second stage was not associated with poor neonatal outcome, prolonged second stage is associated with increased maternal morbidity and instrumental vaginal delivery rates. There is no evidence to support arbitrary time limits for the duration of the second stage. Active pushing is associated with fetal acidosis and denervation injury to maternal perineal muscles (Roberts 2002b). Maternal positions in labour that promote descent of the presenting part are helpful in shortening the duration of the second stage.

The decision to perform instrumental vaginal delivery in theatre indicates the operator anticipates a difficult delivery with a higher than average risk of failure. Trial of instrumental vaginal delivery has been considered an acceptable alternative to caesarean section for delay in the second stage due to a potentially difficult mid‐cavity arrest (Lowe 1987). There are reports that suggest increased maternal and neonatal morbidity following failed trial of instrumental vaginal delivery (Murphy 2003; Sadan 2003; Sheiner 2001) and others suggesting that failed trial of instrumental vaginal delivery does not increase maternal and neonatal morbidity (Murphy 2001b; Revah 1997). Immediate caesarean section without trial of instrumental vaginal delivery may increase caesarean section rate by performing caesarean section in women who could have a successful trial of instrumental vaginal delivery. The fetal head is likely to be impacted in second caesarean section at full cervical dilatation especially following failed instrumental delivery. Disengagement of the deeply wedged head during caesarean section can be difficult as well as traumatic (Blickstein 2004). Techniques for disengagement include pushing by an assistant or pulling the baby by the feet and delivery by breech extraction. Caesarean section also has implications for future pregnancies with an increased risk of repeat operation and scar rupture. However, a difficult instrumental vaginal delivery may be associated with increased neonatal morbidity (Johnson 2004; Sheiner 2001). Long‐term effects of instrumental vaginal delivery include perineal pain, incontinence and sexual problems (Burrows 2004; Liebling 2004).

There is variation in threshold for performing trial of instrumental vaginal delivery . Some practitioners feel that if there is a 50% chance of success, trial of instrumental vaginal delivery is justified. When instrumental vaginal delivery is set up as a trial, high failure rates have been reported (Lowe 1987).

We will not assess in this review the merits of the different instruments used for instrumental vaginal delivery which was the subject of a previous review (Johanson 1999). This review concluded that compared to forceps, the vacuum extractor appeared to reduce maternal morbidity. Local practice and operator preference also influence the choice of instrument.

Objectives

To determine differences in maternal and neonatal morbidity for women where a trial of anticipated difficult instrumental vaginal delivery is conducted in theatre compared to women who have immediate caesarean section in the second stage for maternal or fetal indications.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials comparing trial of instrumental vaginal delivery (vacuum extraction or forceps) in operating theatre with immediate caesarean section (CS) for fetal or maternal indications at full cervical dilatation.

Types of participants

Women in second stage of labour with singleton, term fetus in cephalic presentation requiring operative delivery.

Types of interventions

Instrumental vaginal delivery (forceps or vacuum extraction) conducted in theatre with preparations for proceeding to CS in event of failure.
Caesarean section performed in the second stage of labour without attempting instrumental vaginal delivery.

Types of outcome measures

Maternal
(1) Proportions successful instrumental vaginal delivery with single or sequential instruments and CS after failed instrumental delivery.
(2) Perineal trauma (episiotomy, third and fourth degree tears).
(3) Vaginal lacerations.
(4) Admission to intensive care unit or high dependency unit.
(5) Blood loss (more than 500 ml).
(6) Blood transfusion.
(7) Haemoglobin or haematocrit change.
(8) Postpartum anaemia.
(9) Uterine tears.
(10) Cervical tears.
(11) Puerperal infection (wound infection, endometritis).
(12) Length of hospital stay.
(13) Time to resumption of normal activities.
(14) Maternal satisfaction with birth experience.
(15) Maternal death.

Neonate
(1) Apgar score less than seven at five minutes.
(2) Cord pH.
(3) Admission to neonatal unit.
(4) Duration of admission to neonatal unit.
(5) Trauma (scalp, face lacerations, fractures).
(6) Hypoxic ischaemic encephalopathy (convulsions etc).
(7) Perinatal death.

Search methods for identification of studies

We will contact the Trials Search Co‐ordinator to search the Cochrane Pregnancy and Childbirth Group Trials Register.

The Cochrane Pregnancy and Childbirth Group's trials register is maintained by the Trials Search Co‐ordinator and contains trials identified from:
1. quarterly searches of the Cochrane Central Register of Controlled Trials (CENTRAL);
2. monthly searches of MEDLINE;
3. handsearches of 30 journals and the proceedings of major conferences;
4. weekly current awareness search of a further 37 journals.

Details of the search strategies for CENTRAL and MEDLINE, the list of handsearched journals and conference proceedings, and the list of journals reviewed via the current awareness service can be found in the 'Search strategies for identification of studies' section within the editorial information about the Cochrane Pregnancy and Childbirth Group.

Trials identified through the searching activities described above are given a code (or codes) depending on the topic. The codes are linked to review topics. The Trials Search Co‐ordinator searches the register for each review using these codes rather than keywords.

Data collection and analysis

Selection of studies
Each review author will assess the trials without blinding to the names of authors, institutions, etc. Trials will be evaluated for methodological quality and appropriateness for inclusion without consideration of results. Quality scores will be assigned using the criteria described in the Cochrane Reviewers' Handbook (Alderson 2004).

Each study will be assessed for quality of the concealment of allocation, completeness to follow up, and blinding in the assessment of outcome.

Generation of random allocation sequence: adequate, inadequate, unclear.

Allocation of concealment
A quality score for concealment will be assigned to each trial, using the following criteria:
(A) adequate concealment of allocation, such as telephone randomisation, consecutively numbered sealed opaque envelopes;
(B) unclear whether adequate concealment of allocation;
(C) inadequate concealment of allocation, such as open random number tables.

When the method of allocation is unclear, attempts will be made to contact authors to provide further details.

Completeness to follow up
Completeness to follow up will be assessed using the following criteria:
(A) less than 5% of participants excluded;
(B) 5% to 10% of participants excluded;
(C) more than 10% and up to and including 20% of participants excluded.

Studies will be excluded if:
(1) more than 20% of participants excluded;
(2) more than 20% of analysis not in randomisation groups and not possible to restore participants to correct group;
(3) large difference (more than 10%) in withdrawal of participants between groups.

Blinding
Blinding of outcome assessment (yes/no/unclear).

Quality assessment and data extraction will be performed independently by each review author and differences in interpretation will be resolved by discussion.

Data extraction
Data will be extracted to allow an intention‐to‐treat analysis wherever possible so that women allocated to trial of instrumental delivery who were delivered by caesarean section will be restored to the instrumental vaginal delivery group. We will entere data onto the Review Manager software (RevMan 2003). We will design a data collection form which will contain information about quality and characteristics of the trials (methods, participants, outcome measures and results).

Statistical analyses
For binary outcomes, results of comparisons will be expressed using relative risk with 95% confidence intervals as measure of effect. Weighted mean difference will be used for continuous outcome measures. Data from different trials will be combined if the trials are considered sufficiently similar. Fixed‐effect meta‐analysis will be used for combining data in trials that are judged to be sufficiently similar. If forest plots indicate heterogeneity among the trials included in the analysis, we will use random‐effects meta‐analysis for the overall summary and assessed using I² statistics.

All eligible trials will be included in the primary analysis. We will perform sensitivity analyses for each of the quality factors using subgroups adequate, inadequate and unclear.

In a subgroup analysis we will explore the relationship of epidural use, operator skills and type of instrument to outcome of trial of instrumental vaginal delivery.